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PT. ENSEVAL MEDIKA PRIMA

Authorized Representative in Indonesia

JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
658 Products Represented
161 Manufacturers
Total Products
658
Manufacturers
161
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
141 products
21.4%
Kelas Resiko : B
363 products
55.2%
Kelas Resiko : C
137 products
20.8%
Kelas Resiko : D
17 products
2.6%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (658)
Complete portfolio registered with BPOM

MEDRAD Salient Contrast Injector Wireless

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2025

MEDRAD Salient Contrast Injector Non-Wireless

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2025

HOKAPI™ CUVETTE

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

VITEK MS System and Accessories

Manufacturer:

KRATOS ANALYTICAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 6, 2025

DENSICHECK Plus Instrument for VITEK 2 System and Accessories

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 6, 2025

BIOMERIEUX Mycoline

Manufacturer:

AIDIAN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 2, 2025

BacT/ALERT VIRTUO Microbial Detection System and Accessories

Manufacturer:

BIOMERIEUX INC. (MISSOURI)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 27, 2024

Bact/Alert 3D 240

Manufacturer:

BIOMERIEUX INC. (Missouri)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 27, 2024

BIOMERIEUX Uriline

Manufacturer:

AIDIAN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 27, 2024

FILMARRAY Torch and accessories

Manufacturer:

BIOFIRE DIAGNOSTICS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2024

MEDRAD Salient Contrast Injector Single (Basic and with Wireless RCU)

Manufacturer:

IMAXEON PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 24, 2024

FILMARRAY 2.0 Instrument and Accessories

Manufacturer:

BIOFIRE DIAGNOSTICS, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

VIDAS PC Configuration and Accessories

Manufacturer:

BIOMERIEUX ITALY S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

BIOMERIEUX Saline Solution

Manufacturer:

PiSA Farmaceutica

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 16, 2024

PREVI Color Gram V2 and Accessories

Manufacturer:

ELITechGroup Inc.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

BACT/ALERT 3D 60 and Accessories

Manufacturer:

BIOMERIEUX INC. (Missouri)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2024

ETEST Ceftazidime

Manufacturer:

BIOMERIEUX SA., (La Balme les Grottes)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2024

ETEST® Ampicillin / Sulbactam

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

ETEST Amikacin AK 0.016-256 µg/mL

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

VITEK 2 Compact 30 Configuration and Accessories

Manufacturer:

BIOMERIEUX INC., (MISSOURI)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

VITEK MS MOULD KIT

Manufacturer:

BIOMERIEUX SA (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2024

BACT/ALERT 3D Combo and Accessories

Manufacturer:

BIOMERIEUX INC., (MISSOURI)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 18, 2024

BIOFIRE Blood Culture Identification 2 (BCID2) Panel

Manufacturer:

BIOFIRE DIAGNOSTICS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2024

VITEK 2 AST-GP67 Test Card

Manufacturer:

BIOMERIEUX INC. (MISSOURI)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

VITEK 2 Compact and Accessories

Manufacturer:

BIOMERIEUX INC., (MISSOURI)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

VIDAS HBsAg Ultra (HBS)

Manufacturer:

BIOMERIEUX S.A.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 6, 2024

VITEK 2 AST-YS08

Manufacturer:

BIOMERIEUX INC., (MISSOURI)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

VITEK DENSICHEK and Accessories

Manufacturer:

BIOMERIEUX INC., (Missouri)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

BIOMERIEUX MINI VIDAS and Accessories

Manufacturer:

BIOMERIEUX ITALIA S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

ETEST Piperacillin/Tazobactam (P/T)

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

Etest Ceftolozane/Tazobactam (C/T)

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

BIOMERIEUX Color Gram 2

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 29, 2024

PREVI Color Gram Crystal Violet Solution - RC

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 28, 2024

HEMOSIL D-Dimer 500

Manufacturer:

BIOKIT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

PREVI Color Gram Acetone Safranin Solution -RA1

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2024

PREVI Color Gram Acetone Fuschin Solution - RA3

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2024

VIDAS CMV IgM CMVM

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

BIOMERIEUX Optochine Test (OPTO-F)

Manufacturer:

BIOMERIEUX SA. (Craponne)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

BIOMERIEUX Thioglycollate broth with resazurin

Manufacturer:

BIOMERIEUX SA. (COMBOURG).,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 24, 2024

API 50 CHB/ E Medium

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

VITEK 2 COMPACT 60 and Accessories

Manufacturer:

BIOMERIEUX INC., (Missouri)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

MEDRAD Salient 150cm Extension Tube Single

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MFG., CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

MEDRAD Salient 190mL Syringe with quick fill tube (QFT)

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

MEDRAD Salient 150cm Extension Tube T-Connector

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

VITEK 2 NH

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2024

BACT/ALERT BPA

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 16, 2024

BACT/ALERT BPN

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 16, 2024

VIDAS 3 and Accessories

Manufacturer:

BIOMERIEUX ITALIA S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2024

VITEK 2 AST-GN93

Manufacturer:

BIOMERIEUX INC., (Missouri)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2024

SLIM 2 GP

Manufacturer:

BIOMERIEUX INC., (Missouri)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2024

VITEK 2 AST-ST03

Manufacturer:

BIOMERIEUX INC., (Missouri)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2024

CHROMID MRSA Agar

Manufacturer:

BIOMERIEUX S.A. (CRAPONNE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 15, 2024

VITEK 2 GN Card

Manufacturer:

BIOMERIEUX INC., (MISSOURI)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2024

PREVI Color Gram Fuchsin Solution-RA4

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2024

VITEK 2 AST - N 317

Manufacturer:

BIOMERIEUX INC., (Missouri)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

SLIDEMATE™ Laser Plus Adhesion Microscope Slides

Manufacturer:

NEW ERIE SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 11, 2024

SLIDEMATE™ Laser Microscope Slides

Manufacturer:

NEW ERIE SCIENTIFIC LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 11, 2024

RAPIDEC CARBA NP

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

VITEK 2 YST

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

VITEK 2 ANC

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

BACT/ ALERT FN Plus

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

API 50 CHL Medium

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

BACT/ALERT PF Plus

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

JOLLY 30 PLUS DR

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL SRL., ITALY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

BIOMERIEUX API Suspension Medium

Manufacturer:

BIOMERIEUX SA. (La Balme Les Grottes)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

BIOMERIOUS NIN

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 2, 2024

BIOMERIEUX FB.

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 2, 2024

BIOMERIEUX VPA + VPB

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 2, 2024

BIOMERIEUX Zn

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 1, 2024

BIOMERIEUX ID 32 E

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

BACT/ALERT FA Plus

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

BIOMERIEUX API Listeria

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

CHROMID Candida Agar (CAN 2)

Manufacturer:

BIOMERIEUX SA. (Craponne)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 27, 2024

CHROMID ESBL Agar

Manufacturer:

BIOMERIEUX SA (Craponne)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 27, 2024

API 50 CH

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

API 20 C AUX

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

VIDAS Anti-HEV IgG (HEVG)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 27, 2024

VIDAS Anti-HEV IgM (HEVM)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 27, 2024

BIOMERIEUX Gelose ChromID Strepto B (STRB)

Manufacturer:

BIOMERIEUX SA (Craponne)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 27, 2024

API Coryne

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

API 20 A

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

API 20 E Reagents

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

API 20 NE

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2024

LIVES Testosteron II (TES2)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2024

THERMO SCIENTIFIC INDIKO with ISE And Accessories

Manufacturer:

THERMO FISHER SCIENTIFIC OY.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2024

API Candida

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2024

API Staph

Manufacturer:

BIOMERIEUX SA. (La Balme Les Grottes)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2024

BIOMERIEUX API M Medium

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 24, 2024

BIOMERIEUX Mueller Hinton 2 Gelose/Agar (MH2-D)

Manufacturer:

BIOMERIEUX SA. (Craponne)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2024

BIOMERIEUX Mineral Oil

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 23, 2024

BIOMERIEUX API of Medium

Manufacturer:

BIOMERIEUX SA. (La Balme Les Grottes)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 23, 2024

API 20 Strep

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 23, 2024

API NH

Manufacturer:

BIOMERIEUX SA. (LA BALME LES GROTTES)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 23, 2024

HEMOSIL D-Dimer Controls

Manufacturer:

BIOKIT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2024

MEDRAD Salient Contrast Injector Dual with Wireless RCU

Manufacturer:

IMAXEON PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

MEDRAD Twist & Go Sterile High Pressure Connector Tubing

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

Elva HbA1c Quality Control (HPLC)

Manufacturer:

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2024

VIDAS Anti-TG (ATG)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

VIDAS AMH

Manufacturer:

BIOMERIEUX S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

HEMOSIL D-Dimer HS 500 Controls

Manufacturer:

BIOKIT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2024

BIOMERIEUX Chocolate Agar + Polyvitek (PVX)

Manufacturer:

BIOMERIEUX S.A. (CRAPONNE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 10, 2024

BIOMERIEUX Todd Hewitt Broth + Antibiotiques (TODD H-T)

Manufacturer:

BIOMERIEUX S.A. (CRAPONNE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 9, 2024

VIDAS Anti-HCV

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 4, 2024

MEDRAD Spectris Solaris MRI Integral ''T'' with Check Valve

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 4, 2024

BIOMERIEUX Mac Conkey Agar

Manufacturer:

BIOMERIEUX S.A. (CRAPONNE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 4, 2024

BIOMERIEUX Schaedler Agar + 5 % Sheep Blood

Manufacturer:

BIOMERIEUX S.A. (CRAPONNE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 4, 2024

BIOMERIEUX Columbia Agar + 5% Sheep Blood

Manufacturer:

BIOMERIEUX S.A. (CRAPONNE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 4, 2024

VIDAS Anti-TPO (ATPO)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2024

VIDAS Anti-DENGUE IgM (DENM)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2024

LIVES Anti-DENGUE IgG (DENG)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2024

VIDAS Cortisol S (CORS)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2024

LIVES DENGUE NS1 Ag (DEAG)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2024

VIDAS Protein C

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

HEMOSIL Apixaban Calibrators

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

EPREDIA 10% Neutral Buffered Formalin Prefilled Container

Manufacturer:

AZER SCIENTIFIC LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2024

BIOMERIEUX Mac Conkey agar without crystal violet (MC-D)

Manufacturer:

BIOMERIEUX S.A. (CRAPONNE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2024

VIDAS Anti-HBs Total II (AHBS)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 27, 2024

HEMOSIL Liquid Anti-Xa

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

BIOMERIEUX CLED - Agar

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2024

VIDAS C difficile Toxin A & B

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

HEMOSIL Rivaroxaban Controls

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ELVA Microscope B101

Manufacturer:

OPTO-EDU (BEIJING) CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2024

VIDAS 25 OH Vitamin D Total (VITD)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ELVASENSE Multi-Function Monitoring System

Manufacturer:

TAIDOC TECHNOLOGY CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 26, 2024

VIDAS HBCT Anti - HBc Total II

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 26, 2024

T4 LIVES

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ELVA Applier

Manufacturer:

YUWON MEDITECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2024

HEMOSIL Rivaroxaban Calibrators

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

HEMOSIL Apixaban Controls

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ELVASENSE Uric Acid Test Strip

Manufacturer:

TAIDOC TECHNOLOGY CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

VIDAS CMV IgG Avidity II (CMVA)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 22, 2024

ELVA Microscope T201

Manufacturer:

OPTO-EDU (BEIJING) CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 22, 2024

VIDAS beta 2 Microglobulin

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2024

VIDAS NT pro-BNP2

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2024

VIDAS C. difficile GDH

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

LIVES LH

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

MEDRAD Mark V Provis Sterile Disposable Syringe 150 mL & QFT

Manufacturer:

BAYER MEDICAL CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 20, 2024

VIDAS FSH

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

ACL TOP 550 CTS and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

ACL TOP 300 CTS and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

ACL TOP 350 CTS and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

HEMOSIL dRVVT Screen

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

HEMOSIL Protein S Activity

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

LIVES Toxo IgM (TXM)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 13, 2024

VIDAS Estradiol II E211

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

HEMOSIL La Positive Control

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

VIDAS CA 125 II

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 13, 2024

HOKAPI™ AE180 and Accessories

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2024

MEDRAD Mark 7 Arterion Disposable Syringe 150mL with Quick Fill Tube

Manufacturer:

BAYER MEDICAL CARE, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

HEMOSIL D-Dimer Controls

Manufacturer:

BIOKIT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2024

CT TRI-PAK Sterile Disposable Syringe

Manufacturer:

BAYER MEDICAL CARE, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

Medrad Disposable MRI Kit for 65/115 MR Injector System

Manufacturer:

BAYER MEDICAL CARE, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

HEMOSIL ReadiPlastin

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 8, 2024

HEMOSIL La Negative Control

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

ACL Elite and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

ACL ELITE Pro and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

HEMOSIL von Willebrand Factor Antigen

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

VIDAS CA 15-3

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 8, 2024

VIDAS Progesteron PRG

Manufacturer:

BIOMERIEUX S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

ACL AcuStar and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

HEMOSIL Rinse Solution

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 8, 2024

MEDRAD Stellant Dual Syringe Quad-PAK with QFT

Manufacturer:

BAYER MEDICAL CARE, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

MEDRAD Mark 7 Arterion Injection System

Manufacturer:

BAYER MEDICAL CARE, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

MEDRAD Sterile Disposable MRI Kit

Manufacturer:

BAYER MEDICAL CARE, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

HEMOSIL Special Test Control Level 1

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2024

HEMOSIL Protein C

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2024

HEMOSIL Factor IX Deficient Plasma

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

HEMOSIL Calcium Chloride 0.025 M

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

TSH3 LIVES

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

HEMOSIL APTT-SP (Liquid)

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

HEMOSIL Q.F.A. Thrombin (Bovine)

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

HEMOSIL Low Fibrinogen-Control

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2024

HEMOSIL Liquid Antithrombin

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2024

HEMOSIL Thrombin Time

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2024

HEMOSIL D-Dimer HS 500

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 30, 2024

HEMOSIL Normal Control Assayed

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

HEMOSIL WASH-R EMULSION

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2024

VIDAS CA 19-9™/199

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

HEMOSIL Factor VII Deficient Plasma

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

HEMOSIL UF Heparin Controls

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

HEMOSIL D-Dimer

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

HEMOSIL Heparin Calibrators

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

MEDRAD MRXperion MR Injection System

Manufacturer:

BAYER MEDICAL CARE, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

Elva A1cChek Pro Analyzer

Manufacturer:

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

CK-MB LIVES

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

HEMOSIL Low Abnormal Control Assayed

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

VIDAS Kube Clinical

Manufacturer:

BIOMERIEUX ITALIA S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2024

GEM System Evaluator Lvl 3

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2024

LIVES TOXO IgG II TXG

Manufacturer:

BIOMERIEUX S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

VIDAS HIV DUO Ultra (HIV5)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 11, 2024

HEMOSIL Fibrinogen-C

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

VIDAS EBV VCA/EA IgG (VCAG)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

FPSA LIVES

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

HEMOSIL PT-Fibrinogen HS Plus

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

VIDAS EBV VCA IgM (VCAM)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

VIDAS EBV EBNA IgG (EBNA)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

HEMOSIL Factor VIII Deficient Plasma

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 8, 2024

HEMOSIL LMW Heparin Controls

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 8, 2024

CEA LIVES (S)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 8, 2024

HEMOSIL Special Test Control Level 2

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 8, 2024

HEMOSIL RecombiPlasTin 2G

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2024

Elva A1cChek Pro Test Kit

Manufacturer:

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2024

GEM PREMIER™ 3500 and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

VIDAS HBC IgM II (HBCM)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 5, 2024

HEMOSIL Calibration Plasma

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

HEMOSIL Cleaning Agent

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 5, 2024

E-CARE Medical Gloves - Latex Powdered Examination Gloves

Manufacturer:

SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 5, 2024

HEMOSIL High Abnormal Control Assayed

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

VIDAS Myoglobin (MYO)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

GEM Premier 5000 PAK iQM Sensor dan Reagent Cartridge 16 parameter (pH, pCO2, pO2, Na+, K+, Cl, Ca++, Glocose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, Hhb, sO2

Manufacturer:

INSTRUMENTATION LABORATORIES CO, USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2024

HCG LIVES

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

HEMOSIL Silica Clotting Time

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2024

HEMOSIL Free Protein S

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

HEMOSIL Cleaning Solution

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 4, 2024

HEMOSIL SynthAsil

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2024

GEM Premier 5000 PAK iQM Sensor and Reagent Cartridge 17 Parameter (pH, pCO2, pO2, Na, K, Cl, Ca,Glocose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2)

Manufacturer:

INSTRUMENTATION LABORATORIES CO, USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2024

VIDAS CMV IgG (CMVG)

Manufacturer:

BIOMERIEUX S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

VIDAS vWF

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

BioFire Respiratory Panel 2.1 plus (RP2.1plus)

Manufacturer:

BIOFIRE DIAGNOSTICS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

LIVES Total IgE

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

VIDAS RUB IgM (RBM)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

VIDAS Anti - HAV Total (HAVT)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

VIDAS RUB IgG II (RBG)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

E-CARE Medical Gloves - Nitrile Powder Free Examination Gloves

Manufacturer:

SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 2, 2024

GEM CVP 3

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

VIDAS TPSA

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2024

GEM PREMIER 3500 iQM (pH, pCO2, pO2, HcT, Na+, K+, Ca+)

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2024

GEM CVP 5 tBili

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

ACL TOP 750 CTS and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

GEM System Evaluator Lvl 1

Manufacturer:

INSTRUMENTATION LABORATORY CO.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

GEM PREMIER 3500 PAK iQM (pH, pCO2, pO2, HcT, Na+, K+, Ca++, Glucose and Lactate)

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2024

GEM CVP 2

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

GEM Hematocrit Evaluator 2

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

ACL TOP 750 LAS and Accessories

Manufacturer:

INSTRUMENTATION LABORATORY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

GEM CVP 1

Manufacturer:

INSTRUMENTATION LABORATORIES CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

GEM Hematocrit Evaluator 3

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

GEM System Evaluator Lvl 2

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

GEM CVP 4

Manufacturer:

INSTRUMENTATION LABORATORIES CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

THERMO SCIENTIFIC Cholesterol

Manufacturer:

THERMO FISHER SCIENTIFIC OY.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2024

GEM Hematocrit Evaluator 1

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2024

VOTEM Patient Monitor VP-1200

Manufacturer:

VOTEM CO., LTD, KOREA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2024

GEM PREMIER 3500 (pH, pCO2, pO2, HcT) Sensor and Reagent Catridge

Manufacturer:

INSTRUMENTATION LABORATORY COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 25, 2024

GEM CVP Multipak

Manufacturer:

INSTRUMENTATION LABORATORIES CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

THERMO Cholesterol

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

DRI THC 100 ng/ml Urine Calibrator

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2024

FILMARRAY Meningitis/Encephalitis (ME) Panel

Manufacturer:

BIOFIRE DIAGNOSTICS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 20, 2024

VITEK 2 AST-XN22

Manufacturer:

BIOMERIEUX INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

VIDAS Mumps IgG (MPG)

Manufacturer:

BIOMERIEUX SA., FRANCE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

VIDAS Measles IgG (MSG)

Manufacturer:

BIOMERIEUX SA., FRANCE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2024

VIDAS Varicella-Zoster IgG (VZG)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2024

ELVA HbA1c Reagent Kit (HPLC, Variant Mode)

Manufacturer:

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2024

LIVES AFP

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2024

DRI Ecstasy Calibrators

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

MGC Primary DAU Control Set

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

FUKUDA SANGYO Spiroanalyzer

Manufacturer:

Fukuda Accompaniment. CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

DRI THC 20 ng/ml Urine Calibrator

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

DRI Multi-Drug Urine Calibrator 2

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

VIDAS HAV IgM (HAVM)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

DRI Ecstasy Assay

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

DRI THC 125 ng/ml Urine Control

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

DRI Drugs of Abuse Low Calibrator

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

DRI THC 40 ng/ml Urine Control

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

MGC Select DAU Control Set

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

EPREDIA Stainless Steel Base Molds

Manufacturer:

CELLPATH LTD, UNITED KINGDOM

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2024

Elva HbA1c Analytical Column

Manufacturer:

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD, P.R CHINA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

JOLLY 20 Plus

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL SRL., ITALY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2024

EPREDIA Coverslips

Manufacturer:

EPREDIA LABORATORY PRODUCTS MANUFACTURING (SHANGHAI) CO. LTD, CHINA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2024

DRI THC 50 ng/ml Urine Calibrator

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

JOLLY 4 Plus

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL SRL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

FILMARRAY Pneumonia Panel Plus

Manufacturer:

BIOFIRE DIAGNOSTICS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2024

Elvasense Air Compressor Nebulizer

Manufacturer:

FLAEM NEW, SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

THERMOSCIENTIFIC CRP Plus

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

DRI THC 200 ng/ml Urine Calibrator

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

THERMOSCIENTIFIC HDL Cholesterol

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

DRI THC 75 ng/ml Urine Control

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

Elva HbA1c Calibrator (HPLC)

Manufacturer:

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD, P.R CHINA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2024

FilmArray Gastrointestinal (GI) Panel

Manufacturer:

BIOFIRE DIAGNOSTICS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2024

MGC Clinical DAU Control Set

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

DRI Methadone Assay

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

DRI Amphetamines Assay

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

DRI Opiate Urine Calibrator 3

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

DRI THC 60 ng/ml Urine Control

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

DRI® Cocaine Metabolite Assay

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

DRI Multi Drug Urine Calibrator 1

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

DRI Benzodiazepine Assay

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

DRI Opiate Assay

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2024

THERMO SCIENTIFIC INDIKO And Accessories

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2024

DRI Cannabinoid Assay

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2024

DRI Barbiturate Assay

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

DRI Opiate Calibrators 1

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

DRI 100 mg/dL Alcohol Calibrator

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

DRI Negative Urine Calibrator

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

DRI Multi Drug Urine Calibrator 4

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

DRI Multi-Drug Urine Calibrator 3

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

ELVA HbA1c Reagent Kit (HPLC, Standard Mode)

Manufacturer:

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

DRI 300 mg/dL Alcohol Control

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

DRI 50 mg/dL Alcohol Control

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

DRI Ethyl Alcohol Assay

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

THERMOSCIENTIFIC Specical

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

ELVA Automated HbA1c Analyzer

Manufacturer:

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

DRI Negative Alcohol Calibrator

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 30, 2024

THERMO INDIKO Plus 864 Clinical Chemistry Analyzer and Accessories

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2024

THERMOSCIENTIFIC CK-MB

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

EPREDIA Autostainer 480s and Accessories

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2024

THERMOSCIENTIFIC CK (IFCC)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

THERMOSCIENTIFIC CRP

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

THERMOSCIENTIFIC Albumin MST

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

THERMO Ferritin Calibration Set

Manufacturer:

THERMO FISHER SCIENTIFIC. OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

THERMOSCIENTIFIC Ferritin Control

Manufacturer:

THERMO FISHER SCIENTIFIC, OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

THERMOSCIENTIFIC Specitrol

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

Thermo Scientific Amylase (IFCC)

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

THERMOSCIENTIFIC Creatinine (Enzymatic)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

THERMOSCIENTIFIC HbA1c

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

THERMOSCIENTIFIC Phosphorus

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

PT Module

Manufacturer:

SHANDON DIAGNOSTICS LTD (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

THERMOSCIENTIFIC Utrol High Control H

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

THERMOSCIENTIFIC Ferritin Control High

Manufacturer:

THERMO FISHER SCIENTIFIC. OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

Eppendorf Centrifuge Minispin

Manufacturer:

EPPENDORF SE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 17, 2024

THERMOSCIENTIFIC Utrol

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

THERMOSCIENTIFIC Potassium (K) Micro Volume Electrode

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

THERMO SCIENTIFIC Ferritin

Manufacturer:

THERMO FISHER SCIENTIFIC, OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

THERMOSCIENTIFIC Transferrin

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

EPREDIA Embedding Cassettes Without Lid

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 16, 2024

THERMO SCIENTIFIC Albumin U Control High

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

THERMOSCIENTIFIC Iron

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

THERMO SCIENTIFIC Bilirubin Direct

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

THERMO SCIENTIFIC Specitrol High

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

THERMO Sodium (Na) Micro Volume Electrode

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

THERMOSCIENTIFIC Albumin U Control

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

THERMO SCIENTIFIC Cholinesterase

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 5, 2024

THERMO Chloride (Cl) Micro Volume Electrode

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

THERMO SCIENTIFIC Albumin U Calibrator

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

THERMOSCIENTIFIC Lipase (Colorimetric)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

EPREDIA Stainless Steel Lids

Manufacturer:

RICHARD ALLAN SCIENTIFIC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 3, 2024

Double Cytofunnels™, White

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 3, 2024

THERMO SCIENTIFIC ISE Calibrator 2 & 3

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 1, 2024

THERMO SCIENTIFIC ISE Calibrator 1

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 1, 2024

PrintMate™ Embedding Cassettes with Lids

Manufacturer:

INPLAST PLASTIC & ELECTRONICS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 25, 2024

THERMOSCIENTIFIC Complement C4

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

THERMOSCIENTIFIC HbA1c Control Normal

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

THERMOSCIENTIFIC A1/APO B Calibrator

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

THERMOSCIENTIFIC HbA1c Pretreatment Liquid

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

THERMOSCIENTIFIC Complement C3

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2024

THERMOSCIENTIFIC Apolipoprotein B

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 20, 2024

BIOMERIEUX Brucella Blood Agar (BBA)

Manufacturer:

BIOMERIEUX ESPANA S.A, SPAIN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 19, 2024

THERMOSCIENTIFIC CRP High Sensitivity Control

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

THEMOSCIENTIFIC CRP High Sensitivity

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

THERMOSCIENTIFIC Rheumatoid Factors 2 (RF 2)

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 18, 2024

THERMO FISHER U/ CSF Protein

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

THERMO SCIENTIFIC CRP Plus Calibrator

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

STP 120-3

Manufacturer:

ESPECIALIDADES MEDICAS MYR, S.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 15, 2024

EPREDIA Slide Basket Transfer System

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 15, 2024

GEMINI AS and Accessories

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

THERMO SCIENTIFIC CRP Control High

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2024

KONELAB Rheumatoid Factors Control

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 10, 2024

THERMOSCIENTIFIC CRP Control

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2024

THERMO SCIENTIFIC CRP Calibration Set

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2024

CYTOSPIN 4

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 1, 2024

HM 355S and Accessories

Manufacturer:

THERMO FISHER SCIENTIFIC (SHANGHAI) INSTRUMENTS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 26, 2024

EPREDIA STP 120-1

Manufacturer:

ESPECIALIDADES MEDICAS MYR, S.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 26, 2024

HISTOPLAST Paraffin Pellet

Manufacturer:

SHANDON DIAGNOSTIC LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2024

CAPTURE-R READY SCREEN (3)

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2024

CLEARVUE

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2024

REVOS

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2024

SHANDON PAPSPIN Specimen Collection Kit

Manufacturer:

RICHARD ALLAN SCIENTIFIC LLC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2024

HISTOSTAR

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2024

EPREDIA Cryostar NX70 and Accessories

Manufacturer:

THERMO FISHER SCIENTIFIC (SHANGHAI) INSTRUMENTS CO. LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 22, 2024

EXCELSIOR AS

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 21, 2024

SHANDON Papspin ™ Liquid-based Cytology Preparation System

Manufacturer:

SHANDON DIAGNOSTICS LIMITED (A SUBSIDIARY OF EPREDIA)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 9, 2024

PrintMate™ Slotted Cassette with Lids White

Manufacturer:

INPLAST PLASTIC & ELECTRONIC (SUZHOU) CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 9, 2024

FA-TECH Biopsy Laser cassettes in Striped Stacks

Manufacturer:

FA-TECH DIAGNOSTICS EUROPA BV

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 7, 2024

FA-TECH Laser Embedding Cassettes in Taped Stacks

Manufacturer:

FA-TECH DIAGNOSTICS EUROPA BV

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2024

FA-TECH Slotted Cassetes w/ Front Tab in Taped Stack

Manufacturer:

FA-TECH DIAGNOSTICS EUROPA BV

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2024

Rapid-Chrome™ Papanicolaou Staining Kit

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 30, 2024

Cytoblock™ Replacement Reagent

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 30, 2024

Histoplast PE

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2024

CYTOBLOK™ Kit

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 24, 2024

KWIK-DIFF™ Stain Kit

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 24, 2024

MGE SAM Emergency Portable Suction

Manufacturer:

MG ELECTRIC (COLCHESTER) LIMITED,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 16, 2024

MGE Suction Unit

Manufacturer:

MG ELECTRIC (COLCHESTER) LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2024

MGE Suction Unit

Manufacturer:

MG ELECTRIC (COLCHESTER) LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2024

MGE Suction Unit

Manufacturer:

MG ELECTRIC (COLCHESTER) LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2024

HOKKAIDO™ T4

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2024

HOKKAIDO™ T3

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2024

EPPENDORF REFERENCE 2 Multi 8 - Channel and Accesories

Manufacturer:

EPPENDORF SE.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 22, 2023

HOKAPI™ HBS Ag

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD, CHINA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 19, 2023

E-CARE safety I.V. Catheter with port - PUR

Manufacturer:

DISPOSAFE HEALTH AND LIFECARE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2023

TAIDOC Total Cholesterol Control Solution L1

Manufacturer:

TAIDOC TECHNOLOGY CORPORATION,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

ELVACATH Straight - FEP Sterile I.V.Catheter

Manufacturer:

DISPOSAFE HEALTH AND LIFECARE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2023

E-CARE I.V. Catheter with port PUR

Manufacturer:

DISPOSAFE HEALTH AND LIFECARE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2023

TAIDOC Blood Glucose Control Solution W2

Manufacturer:

TAIDOC TECHNOLOGY CORPORATION,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

HOKAPI™ Substrate Solution 2

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 17, 2023

MAS® chemTRAK H, Level 3

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2023

TAIDOC Uric Acid Control Solution (L2)

Manufacturer:

TAIDOC TECHNOLOGY CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

TAIDOC Uric Acid Control Solution (L1)

Manufacturer:

TAIDOC TECHNOLOGY CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

Instant Eosin Aqueous (Series S)

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2023

EPREDIA EA-50 (Series S)

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2023

Instant Hematoxylin Kit

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2023

EPREDIA Mucolexx ™

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2023

HOKKAIDO™ FT3

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD, CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

Hokapi™ HBE AG

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD, CHINA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 10, 2023

HOKAPI™ TSH

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD, CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

MAS chemTRAK H Level 2

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

EPREDIA 100% Dehydrant

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 4, 2023

FORMAL-FIXX™ Concentrate

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 4, 2023

EPREDIA Orange G-6 (Series S)

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 4, 2023

Hokap™ FT4

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD, CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2023

EPREDIA 10% Neutral Buffered Formalin

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2023

TBD-1 Rapid Decalcifier

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2023

HOKAPI ™ Substrate Solution 1

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2023

CYTORICH RED™ Collection Fluid

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2023

NOVACLONE Anti-A Murine Monoclonal (Manual and Galileo)

Manufacturer:

DOMINION BIOLOGICALS LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2023

HOKAPI™ Cleaning Solution

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 17, 2023

HOKAPI™ Cleaning

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 17, 2023

NOVACLONE Anti-D IgM + IgG Monoclonal Blend (Manua

Manufacturer:

DOMINION BIOLOGICALS LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2023

NOVACLONE Diluent Control (Manual dan Galileo)

Manufacturer:

DOMINION BIOLOGICALS LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

NOVACLONE Anti-B Murine Monoclonal (Manual dan Galileo)

Manufacturer:

DOMINION BIOLOGICALS LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2023

ONPG Disc (ONPG)

Manufacturer:

BIOMERIEUX SA (CRAPPONE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2023

IMMUCOR Anti-IgG,-C3d; Polyspecific (Murine Monoclonal) (Green or Uncolored) Gamma Clone

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

IMMUCOR Anti-S (Monoclonal) Gamma-clone

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

ELVASENSE General Lancets

Manufacturer:

TIANJIN HUAHONG TECHNOLOGY CO., LTD., CHINA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

ETEST Ciprofloaxacin (CI)

Manufacturer:

BIOMERIEUX SA. (PORT MICHAUD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

EPPENDORF Centrifuge 5427 R and Accessories

Manufacturer:

EPPENDORF CENTRIFUGES, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

IMMUCOR Anti - s (Monoclonal) Gamma-clone

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 30, 2023

CAPTURE-P Control Set

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2023

PANOCELL

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

PANOCELL Ficin-Treated

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

BIOMERIEUX Color Gram 2 (Color Gram 2 R1 – F)

Manufacturer:

RAL DIAGNOSTICS, FRANCE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 19, 2023

IMMUCOR Specimen Diluent

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2023

EPPENDORF Centrifuge 5702 and Accessories

Manufacturer:

EPPENDORF SE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

MAS® Diabetes Liquid Assayed Diabetes Control

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

EPPENDORF Centrifuge 5420 and Accessoriess

Manufacturer:

EPPENDORF ZENTRIFUGEN GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

IMMUCOR Anti-Jka (Monoclonal) Gamma-clone

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 12, 2023

ELVASENSE Blood Pressure Monitor

Manufacturer:

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2023

WARM™ (Warm Autoantibody Removal Medium)

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

RED BLOOD CELL (RBC) STORAGE SOLUTION

Manufacturer:

IMMUCOR INC., USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2023

CAPTURE-R Ready Indicator Red Cells

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

IMMUCOR Gamma EGA Kit

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

GEM PREMIER 4000 PAK IQM Sensor dan Reagent Cartridge 14 parameter (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2)

Manufacturer:

INSTRUMENTATION LABORATORIES CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

CAPTURE-R Ready Screen Pooled Cells

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2023

IMMUCOR Anti-Kpa

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2023

RESt (Rabbit Erythrocyte Stroma for Adsorption of Cold Agglutinins Anti-I , Anti-H or Anti-IH)

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2023

IMMUCOR Weak D Cells

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

IMMUCOR Anti-Lea (Murine Monoclonal) Gamma Clone

Manufacturer:

IMMUCOR INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2023

Anti-Leb (Murine Monoclonal) Gamma Clone

Manufacturer:

IMMUCOR INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

IMMUCOR Complement Control Cells

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

Gamma ELU-KIT II

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

EPPENDORF Reference 2 Adjustable

Manufacturer:

EPPENDORF SE.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 20, 2023

IMMUCOR Anti-Fya (Monoclonal) Gamma-clone

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2023

ETEST Gentamicin (GM)

Manufacturer:

BIOMERIEUX SA. (PORT MICHAUD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

REFERENCELLS - 2 (Group A1 and B)

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2023

IMMUCOR Reagent Red Blood Cells CAPTURE-R Ready-Screen (I and II)

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

EPPENDORF RESEARCH Plus 3121

Manufacturer:

EPPENDORF SE.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 15, 2023

ELVASENSE Blood Pressure Monitor

Manufacturer:

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD, CHINA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2023

REFERENCE 2 Fixed Volume and Accessories

Manufacturer:

EPPENDORF SE.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 14, 2023

IMMUCOR Anti-H Lectin

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2023

PANOSCREEN I, II and III

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2023

Eppendorf Centrifuge 5702R

Manufacturer:

EPPENDORF SE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2023

EPPENDORF Centrifuge 5810 and Accessories

Manufacturer:

EPPENDORF ZENTRIFUGEN GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2023

CorQC™ Test System

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2023

PANOSCREEN I and II

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 10, 2023

IMMUCOR Gamma PeG

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 10, 2023

Eppendorf Centrifuge 5418R and Accessories

Manufacturer:

EPPENDORF ZENTRIFUGEN GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2023

REFERENCELLS-1 (Group A2)

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

IMMUCOR Phix (Phosphate Buffer Concentrate)

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 7, 2023

CAPTURE LISS

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

CHECKCELL IgG-Coated Pooled Red Cells Antiglobulin Control

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2023

CAPTURE-R Ready-ID

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 5, 2023

IMMUCOR Anti-Jkb (Monoclonal) Gamma-clone

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 4, 2023

WB corQC

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2023

REFERENCELLS-4 (Group A1, A2, B dan O)

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2023

CORQC Extend Standard

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2023

DAT Positive Control Cell

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2023

EPPENDORFCentrifuge 5810R and Accessories

Manufacturer:

EPPENDORF ZENTRIFUGEN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

EPPENDORF Centrifuge 5430R and Accessories

Manufacturer:

EPPENDORF ZENTRIFUGEN GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

IMMUCOR Gamma Lewis Blood Group Substance

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2023

CAPTURE-R Select

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 28, 2023

EPPENDORF Centrifuge 5430 and Accessories

Manufacturer:

EPPENDORF MANUFACTURING CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

IMMUCOR Gamma P1 Blood Group Substance

Manufacturer:

IMMUCOR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2023

CAPTURE-P Indicator Red Cell

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2023

CAPTURE-P

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

BioFire Joint Infection (JI) Panel

Manufacturer:

BIOFIRE DIAGNOSTICS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2023

EPPENDORF Centrifuge 5804 R and Accessories

Manufacturer:

EPPENDORF SE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 18, 2023

EPPENDORF Centrifuge 5804 and Accessories

Manufacturer:

EPPENDORF SE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 18, 2023

EPPENDORF Centrifuge 5910 Ri and Accessories

Manufacturer:

EPPENDORF SE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

CMT Plates

Manufacturer:

IMMUCOR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 15, 2023

IMMUCOR Echo Lumena™

Manufacturer:

AGILENT TECHNOLOGIES, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2023

EPREDIA Shandon-Mount ™

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2023

EPREDIA Reagent Alcohol

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2023

EZ-MOUNT™

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2023

EPREDIA Bluing Reagent (Series S)

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2023

CYTOSPIN Collection Fluid

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2023

Rapid-Chrome™ Kwik-Diff™ Staining Kit

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2023

Cryomatrix

Manufacturer:

RICHARD-ALLAN SCIENTIFIC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2023

INSTAN EOSIN ALCOHOLIC

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 27, 2023

BIOMERIEUX Thioglycollate broth with resazurin

Manufacturer:

BIOMERIEUX SA. (PORT MICHAUD)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 27, 2023

Xylene

Manufacturer:

RICHARD-ALLAN SCIENTIFIC LLC, USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 24, 2023

ARGENE SARS-COV-2 R-GENE SPINNER

Manufacturer:

BIOMERIEUX SA, (LOUIS PASTEUR)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ELVA Ultrasonography 9

Manufacturer:

NEUSOFT MEDICAL SYSTEMS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2023

SlideMate™ Plus Adhesion Microscope Slides White Tab

Manufacturer:

NEW ERIE SCIENTIFIC LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 11, 2023

SlideMate™ Microscope Slides White Tab

Manufacturer:

NEW ERIE SCIENTIFIC LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 11, 2023

E-CARE Safety I.V. Catheter Straight - PUR

Manufacturer:

DISPOSAFE HEALTH AND LIFECARE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2023

THERMO SCIENTIFIC Magnesium

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2023

ELVA Ligation Clip

Manufacturer:

YUWON MEDITECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 18, 2023

immuClone Rh-Hr Control

Manufacturer:

IMMUCOR MEDIZINISCHE DIAGNOSTIK GMBH, GERMANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2023

NEO IRIS

Manufacturer:

STRATEC BIOMEDICAL AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 12, 2023

IMMUCOR GALILEO SYSTEM LIQUID CONCENTRATE

Manufacturer:

IMMUCOR MEDIZINISCHE DIAGNOSTIC GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 28, 2023

ETEST Benzylpenicillin (PG)(0.016-256µg/mL)

Manufacturer:

BIOMERIEUX SA. (PORT MICHAUD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2023

ETEST Metronidazole (MZ)(0.016-256µg/mL)

Manufacturer:

BIOMERIEUX SA. (PORT MICHAUD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ETEST Cefoxitin (FX)(0.016-256µg/mL)

Manufacturer:

BIOMERIEUX SA. (PORT MICHAUD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ETEST Clindamycin (CM) (0.016-256 µg/mL)

Manufacturer:

BIOMERIEUX SA. (PORT MICHAUD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ETEST Imipenem (IP) (0.002-32 µg/mL)

Manufacturer:

BIOMERIEUX SA. (PORT MICHAUD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

E-CARE Film I.V. Dressing

Manufacturer:

YAFHO BIO- TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 14, 2023

ELVASENSE Blood Pressure Monitor

Manufacturer:

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2023

GMATE Control Solution Normal

Manufacturer:

PHILOSYS, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2023

ELVASENSE ON Blood Sugar Monitor

Manufacturer:

PHILOSYS, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2023

ELVASENSE SMART Blood Sugar Monitor

Manufacturer:

PHILOSYS, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2023

ELVASENSE Voice Blood Sugar Monitor

Manufacturer:

PHILOSYS, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2023

ELVASENSE Strip Blood Sugar Monitor Device

Manufacturer:

PHILOSYS, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 23, 2023

VITEK MS Prime and Accessories

Manufacturer:

KMC SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2023

ELVASENSE Insulin Pen Needle

Manufacturer:

TIANJIN HUAHONG TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

ELVA Microscope T203

Manufacturer:

OPTO-EDU (BEIJING) CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 30, 2022

ZYM B

Manufacturer:

BIOMERIEUX SA, FRANCE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 26, 2022

ELVA PACS

Manufacturer:

TECHHEIM CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2022

VITEK MS Mycobacterium/Nocardia Kit

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

CHROMID™ Salmonella Agar

Manufacturer:

BIOMERIEUX ESPANA S.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 19, 2022

BIOMERIEUX VP 1 + VP 2

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

VITEK MS-FA

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

Biomerieux Blood Agar (BASA-D)

Manufacturer:

BIOMERIEUX SA, FRANCE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

BCP

Manufacturer:

BIOMERIEUX SA, FRANCE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

VIDAS® PTH (1-84)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

BIOMERIEUX Sabouraud Chloramphenicol 2 Agar

Manufacturer:

BIOMERIEUX SA, FRANCE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

BIOMERIEUX PYZ

Manufacturer:

BIOMERIEUX SA, FRANCE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

VITEK MS-CHCA matrix

Manufacturer:

BIOMERIEUX SA., FRANCE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

VIDAS Ferritin

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

HOMECHOICE Claria APD Cycler

Manufacturer:

BAXTER HEALTHCARE S.A., SINGAPORE BRANCH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

ZYM A

Manufacturer:

BIOMERIEUX SA, FRANCE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2022

BIOMERIEUX API NaCI 0,85% Medium

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 25, 2022

VIDAS Toxo IgG Avidity/ TXGA

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2022

VIDAS HBe/ Anti HBeT

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 22, 2022

TSH LIVES

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2022

BIOMERIEUX ATB Fungus 3

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

BIOMERIEUX ATB™ ANA

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

API 20 E

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 7, 2022

PREVI Color Gram Iodine Solution - RB

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 4, 2022

FT3 LIVES

Manufacturer:

BIOMERIEUX S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2022

T3 LIVES

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

DEMESILK Silk Nonabsorbable Suture

Manufacturer:

DEMETECH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2022

ELVA Swap

Manufacturer:

YUWONMEDITECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

BIOMERIEUX XYL (Xylene)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

BIOMERIEUX TDA

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2022

BIOMERIEUX James

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 24, 2022

FT4N LIVES

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

BIOMERIEUX API CAMPY

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

BIOMERIEUX McFarland Standard

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

BIOMERIEUX EHR

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2022

ELVA Applier

Manufacturer:

YUWON MEDITECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 18, 2022

BIOMERIEUX NIGHT 1 + NIGHT 2

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2022

E-CARE Nitrile Examination Gloves

Manufacturer:

TOP GLOVE SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 10, 2022

E-CARE Surgi Glove Lightly Powdered Surgical Gloves

Manufacturer:

TG MEDICAL, SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2022

E-CARE Surgi Glove Powder Free Surgical Glove

Manufacturer:

TG MEDICAL SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2022

ELVA Ultrasonography 11

Manufacturer:

NEUSOFT MEDICAL SYSTEMS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

Elva Ultrasonography 15

Manufacturer:

NEUSOFT MEDICAL SYSTEMS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

E-CARE Suction Connecting Tube

Manufacturer:

WELL LEAD MEDICAL CO LTD PR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2022

THERMOSCIENTIFIC CALCIUM

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

E-CARE Suction Connecting Tube with Yankauer

Manufacturer:

WELL LEAD MEDICAL CO LTD, P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

THERMO SCIENTIFIC Bilirubin Total (DCA)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2022

THERMOSCIENTIFIC UREA

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

THERMOSCIENTIFIC ALT/GPT (IFCC)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2022

THERMO SCIENTIFIC UREA

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2022

THERMO FISHER Alkaline Phosphatase (IFCC) Plus

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2022

NORTROL

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2022

THERMO SCIENTIFIC eCal

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2022

THERMO SCIENTIFIC Creatinine (Jaffe)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2022

THERMO SCIENTIFIC Triglycerides

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2022

THERMO SCIENTIFIC HDL/LDL Calibrator

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2022

THERMO SCIENTIFIC Lipotrol

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2022

THERMO SCIENTIFIC Apolipoprotein A1

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

THERMO SCIENTIFIC Lipotrol HDL/LDL Abnormal

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

THERMO FISHER Uric Acid (AOX)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

THERMOSCIENTIFIC LDH (IFCC)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

HOKAPI™ AE180 and Accessories

Manufacturer:

SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2022

MEDRAD CENTARGO CT Injection Sytem

Manufacturer:

IMAXEON, PTY LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

MEDRAD Spectris Solaris EP MR Injection System

Manufacturer:

BAYER MEDICAL CARE, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 23, 2022

MEDRAD Centargo Day Set

Manufacturer:

GERRESHEIMER REGENSBURG GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 18, 2022

SKINTACT ECG Electrode

Manufacturer:

LEONHARD LANG GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2022

MEDRAD Low Pressure Connecting Tubing 60" (152 cm)

Manufacturer:

BAYER MEDICAL CARE, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2022

MEDRAD Centargo Patient Line

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2022

THERMOSCIENTIFIC D-DIMER

Manufacturer:

THERMO FISHER SCIENTIFIC OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2021

N-IDEAL Vacuum Extractor

Manufacturer:

NAKAMURA MEDICAL INDUSTRY CO., LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2021

N-IDEAL Infant Incubator

Manufacturer:

NAKAMURA MEDICAL INDUSTRY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

N-IDEAL Infant Incubator

Manufacturer:

NAKAMURA MEDICAL INDUSTRY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

MEDRAD Stellant CT Injection System

Manufacturer:

BAYER MEDICAL CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

MEDRAD Centargo Replacement Spike

Manufacturer:

B.BRAUN AVITUM ITALY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

FUKUDA SANGYO Spiroanalyzer

Manufacturer:

FUKUDA SANGYO CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2021

Elva Hx Control Set (L-N-H)

Manufacturer:

R&D SYSTEM INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

GEM PREMIER 4000 PAK iQM

Manufacturer:

INSTRUMENTATION LABORATORIES CO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2021

SURGIGUARD FIBRILLAR

Manufacturer:

SAMYANG HOLDINGS CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 12, 2021

SURGIGUARD FABRIC

Manufacturer:

SAMYANG HOLDINGS CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 8, 2021

FUKUDA Sangyo Spiroanalyzer

Manufacturer:

FUKUDA SANGYO. CO. LTD., TAKATA FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2021

SURGIGUARD Non-Woven

Manufacturer:

SAMYANG HOLDINGS CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 7, 2021

ELVASENSE VOICE

Manufacturer:

PHILOSYS, CO., LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2021

SURGIGUARD Original

Manufacturer:

SAMYANG HOLDINGS CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 6, 2021

DEMESORB Absorbable Polyglycolic PGA Suture

Manufacturer:

DEMETECH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2021

DEMECAPRONE Absorbable Poligecaprone 25 Surgical Suture

Manufacturer:

DEMETECH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2021

DEMELON Nylon Non Absorbable Suture (Multifilament)

Manufacturer:

DEMETECH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 30, 2021

DEMELON Nylon Non Absorbable Suture (Monofilament)

Manufacturer:

DEMETECH CORPORATION INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 30, 2021

DEMEDAC Polyester Nonabsorbable Suture

Manufacturer:

DEMETECH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 27, 2021

ELVASENSE ORIGIN

Manufacturer:

PHILOSYS, CO., LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2021

DEMEGUT Chromic - Absorbable Chromic Catgut Suture

Manufacturer:

DEMETECH CORPORATION INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 24, 2021

DEMECRYL Absorbable Poly(glicolic/L lactide) PGLA suture

Manufacturer:

DEMETECH CORP

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 19, 2021

DEMEQUICK Absorbable (Polyglicolic/L-Lactide) PGLA Suture

Manufacturer:

DEMETECH CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 17, 2021

DEMELENE - Polypropylene Non-absorbable suture

Manufacturer:

DEMETECH CORPORATION INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 16, 2021

DEMEGUT Plain - Absorbable Plain Catgut Suture

Manufacturer:

DEMETECH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 16, 2021

ELVASENSE ON

Manufacturer:

PHILOSYS CO., LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 14, 2021

DEMEBOND - Polyester non absorbable suture

Manufacturer:

DEMETECH CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 13, 2021

LIVES SARS-COV-2 IgM (9COM)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2021

VIDAS SARS-COV-2 IgG (9COG)

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2021

BMI Radiographic Systems

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2021

DIRUI H Series urine Analyzer Calibration Liquid for Turbidity

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2021

GEM CVP 2 with CO-Ox

Manufacturer:

INSTRUMENTATION LABORATORIES CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

Elva H3D Hematology Analyzer

Manufacturer:

DIATRON MI ZRT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

EMP Connection Suction Drainage Tube

Manufacturer:

SUNDER BIOMEDICAL TECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2021

ELVA H3D Dill Diff

Manufacturer:

DIATRON MI ZRT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2021

Elva Hx Hypoclean

Manufacturer:

DIATRON MI ZRT.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 30, 2021

ELVA Hx Cleaner

Manufacturer:

DIATRON MI ZRT.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 25, 2021

BMI Digital Mobile C-Arm Fluoroscopic/Radiographic

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2021

RAL STAINER And Accesories

Manufacturer:

ILSA Ltd.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2021

E-CARE Island Film Dressing

Manufacturer:

YAFHO BIO- TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

NANOLET Lankets

Manufacturer:

DONG BANG MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 26, 2020

VIKIA HBsAg

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 26, 2020

VIKIA HIV 1/2

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 21, 2020

BMI BHT-TA DR

Manufacturer:

ARCOM INTERNATIONAL SRL., ITALY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2020

MB/ BACT Antibiotic Supplement Kit

Manufacturer:

BIOMERIEUX INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 28, 2020

Elvasense Portable Nasal Washer

Manufacturer:

FLAEM NEW, SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2020

ELVASENSE Nasal Washer Kit

Manufacturer:

FLAEM NEW SPA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 16, 2020

BIOMERIEUX XLD Agar

Manufacturer:

BIOMERIEUX SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 12, 2020

BIOMERIEUX Gelose TSI Agar (TSI - D)

Manufacturer:

BIOMERIEUX SA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 12, 2020

VOTEM Patient Monitor VP-700

Manufacturer:

VOTEM CO., LTD, KOREA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

VOTEM Patient Monitor

Manufacturer:

VOTEM CO., LTD, KOREA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2020

VOTEM Patient Monitor VP-1000

Manufacturer:

VOTEM CO., LTD, KOREA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2020

BIOBASE PATHOLOGY WORKSTATION

Manufacturer:

JINAN BIOBASE BIOTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 16, 2020

KIT RAL Stainer Fluo-RAL

Manufacturer:

RAL DIAGNOSTIC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 1, 2020

KIT RAL Stainer Cold-ZN

Manufacturer:

RAL DIAGNOSTICS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 29, 2020

BMI Radiographic Systems

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2020

BMI JOLLY 30 Plus and Accessories

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2020

YOSHIELD Disposable Coverall

Manufacturer:

HENAN YOSHIELD MEDICAL PRODUCTS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 15, 2020

THERMOSCIENTIFIC Magnesium

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2020

THERMOSCIENTIFIC Lipoprotein (A) Control High

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2019

THERMOSCIENTIFIC Acid Phosphatase

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2019

THERMOSCIENTIFIC Lipoprotein (a) Control

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2019

THERMOSCIENTIFIC Lipoprotein (a)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

THERMOSCIENTIFIC alpha-HBDH

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 6, 2019

THERMOSCIENTIFIC Calcium

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2019

KONELAB Bilirubin Total (NBD)

Manufacturer:

THERMO FISHER SCIENTIFIC OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2019

ELVASENSE Blood Pressure Monitor

Manufacturer:

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD, CHINA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2019

MGE Nebulizer

Manufacturer:

MG ELECTRIC (COLCHESTER) LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2019

RENMED A.V Fistula Needle Set

Manufacturer:

SUNDER BIOMEDICAL TECH CO., LTD., PAO-CHUNG HSIANG FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 22, 2018

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025