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PT. BRIDGE TWO

Authorized Representative in Indonesia

Jl. Petojo Melintang No. 17
267 Products Represented
77 Manufacturers
Total Products
267
Manufacturers
77
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
41 products
15.4%
Kelas Resiko : B
152 products
56.9%
Kelas Resiko : C
44 products
16.5%
Kelas Resiko : D
30 products
11.2%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (267)
Complete portfolio registered with BPOM

TECHNOCLONE AK-Calibrant

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

TECHNOCLONE Coagulation Reference

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

TECHNOCLONE Coagulation Control A

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2025

TC Thrombin Reagent

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2025

TECHNOCLONE Fibrinogen Reagent Kit

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

ACTI-LANCE Lite Safety Lancet 28G

Manufacturer:

HTL-STREFA S.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2025

TC Coagulation Control AK

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2025

TECHNOCHROM ATIII Kit

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

EPIX Laparoscopic Grasper

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

MEDISAFE Solo, safety lancets

Manufacturer:

HTL-STREFA S.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 30, 2025

TC Coagulation Control N

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

PARKER FLEX-TIP® PFNC (Preformed Nasal Cuffed)

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

PARKER FLEX-TIP® PFOC (Preformed Oral Cuffed)

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

PARKER FLEX-TIP® PFNU (Preformed Nasal Uncuffed)

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

PARKER Flex-Tip PFRU (Reinforced Uncuffed)

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

DAPTTIN TC

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2025

PARKER FLEX-TIP® PFOU (Preformed Oral Uncuffed)

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2025

KII Optical Access System with Z-Thread Sleeve

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

GELPORT Hand Access Laparoscopic System

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

PARKER Flex-Tip PFRC (Reinforced Cuffed)

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

PARKER FLEX-TIP PFUO (Uncuffed)

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

GELPOINT Advanced Access Platform

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

EPIX Laparoscopic Scissors

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2025

TECHNOLEIA D-Dimer Control High

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 2, 2025

TECHNOPLASTIN HIS f. Ceveron

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 2, 2025

TECHNOLEIA D-Dimer Control Low

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 2, 2025

TECHNOLEIA D-Dimer Latex Kit

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 2, 2025

BD Ultra-Fine™ Insulin Syringes

Manufacturer:

BD MEDICAL DIABETES CARE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2024

ALEXIS Wound Protector-Retractor

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

KII Fios First Entry with Z-thread Sleeve

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2024

KII Shielded Bladed Access System with Advance Fixation Sleeve

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2024

TECNIS 1-Piece IOL

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 13, 2024

TECNIS Symfony Extended Range of Vision IOL

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 13, 2024

TECNIS Symfony Extended Range of Vision IOL

Manufacturer:

AMO GRONINGEN B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 13, 2024

TECNIS Foldable Acrylic IOLs with OptiEdge Design

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 13, 2024

TECNIS Symfony Extended Range of Vision Toric IOL

Manufacturer:

AMO GRONINGEN B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 13, 2024

TECNIS Eyhance IOL with TECNIS Simplicity™ Delivery System

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 13, 2024

TECNIS Symfony Extended Range of Vision Toric IOL

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 13, 2024

A Vitan Inserter folder

Manufacturer:

DUCKWORTH & KENT, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 12, 2024

CATALYS Precision Laser System

Manufacturer:

AMO MANUFACTURING USA, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2024

TECNIS 1-Piece IOL with SmartLOAD™ Delivery Technology

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 5, 2024

SENSAR 1-Piece IOL

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 3, 2024

Double Lumen Spray Probe for Fibrin Sealing, with Gas Connector

Manufacturer:

H.+H. MASLANKA CHIRURGISCHE INSTRUMENTE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2024

SENSAR Foldable IOL with OptiEdge Design

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 3, 2024

SENSAR 1-Piece IOL with SmartLOAD Delivery Technology

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 3, 2024

KII Optical Access System with Advance Fixation Sleeve

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2024

HEALON GV PRO Ophthalmic Viscosurgical Device

Manufacturer:

AMO UPPSALA AB

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 26, 2024

HEALON5 PRO sterile viscoelastic solution for intraocular use

Manufacturer:

AMO UPPSALA AB

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 26, 2024

KII Blunt Tip Access System

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2024

KII Low Profile Optical Access System

Manufacturer:

APPLIED MEDICAL RESOURCES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2024

WHITESTAR SIGNATURE PRO Phacoemulsification System

Manufacturer:

AMO MANUFACTURING USA, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2024

TECNIS Eyhance IOL

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 22, 2024

TECNIS Eyhance IOL

Manufacturer:

AMO GRONINGEN B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 22, 2024

THE UNFOLDER Emerald Series Cartridge

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 20, 2024

THE UNFOLDER Platinum 1 Series Cartridge Implantation System

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 20, 2024

3M Surgical Clipper Professional

Manufacturer:

RAYMOND (PANYU NANSHA) ELECTRICAL APPLIANCES DEVELOPMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 18, 2024

3M Attest Mini Auto-Reader

Manufacturer:

BENCHMARK ELECTRONICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2024

3M Bair Hugger Patient Warming System

Manufacturer:

BENCHMARK ELECTRONICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2024

LABCHOICE Decabio Dengue NS1 Antigen Rapid Test Kit (Colloidal Gold)

Manufacturer:

BEIJING ZHONGJIAN ANTAI DIAGNOSTIC TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

LABCHOICE DecaBio Dengue IgG/IgM Antibody Combined Rapid Test Kit (Colloidal Gold)

Manufacturer:

BEIJING ZHONGJIAN ANTAI DIAGNOSTIC TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

BD AutoShield Duo™ Pen Needle

Manufacturer:

BECTON, DICKINSON AND COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

HEALON5 Pro viscoelastic solution for intraocular use

Manufacturer:

AMO UPPSALA AB

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 26, 2024

HEALON PRO Viscoelastic Solution For Intraocular Use

Manufacturer:

AMO UPPSALA AB

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 22, 2024

HEALON GV Pro viscoelastic solution for intraocular use

Manufacturer:

AMO UPPSALA AB

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 22, 2024

LABCHOICE Drug Abuse Test, Multi 10 (AMP1000/MOP300/THC50/MET1000/COC300/BZO300/SOMA2000/K2-50/ETG500/PCP25)

Manufacturer:

PROMETHEUS BIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2024

3M BAIR HUGGER Patient Warming System

Manufacturer:

3M COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

3M COMPLY Steam Chemical Indicator Strips

Manufacturer:

PROPPER MANUFACTURING COMPANY, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

3M COMPLY Bowie-Dick Plus Type Test Pack

Manufacturer:

3M COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

3M Surgical Clipper Professional

Manufacturer:

WAHL CLIPPER CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 1, 2024

OIC Intramedullary Screw System

Manufacturer:

MICROWARE PRECISION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2024

OIC Variable Angle Small Fragment Locking Plate System

Manufacturer:

THE ORTHOPAEDIC IMPLANT COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2024

LABCHOICE DECABIO GH Glucose Control Solution, Level 2

Manufacturer:

TIANJIN EMPECS MEDICAL DEVICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2024

STARDEC ElastoFix

Manufacturer:

KOB GMBH,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 20, 2024

LABCHOICE DECABIO GH Glucose Control Solution, Level 3

Manufacturer:

TIANJIN EMPECS MEDICAL DEVICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2024

THE UNFOLDER Emerald Series Handpiece

Manufacturer:

RMS COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 19, 2024

A&D Automatic Blood Pressure Monitor

Manufacturer:

A&D MANUFACTURING COMPANY, LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2024

AURUM Extra-Corporeal Circuit Tube

Manufacturer:

TIANJIN PLASTICS RESEARCH INSTITUTE CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

BAERVELDT Glaucoma Implant

Manufacturer:

AMO GRONINGEN B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 10, 2024

Healon Endocoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate)

Manufacturer:

LIFECORE BIOMEDICAL, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 10, 2024

3M Attest Rapid Readout Biological Indicator (1295)

Manufacturer:

3M COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2024

LABCHOICE Drug Abuse Test, Multi 6 (AMP1000/MOP300/COC300/THC50/MET500/BZO300)

Manufacturer:

PROMETHEUS BIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2024

PREVISCAID Ophthalmic Viscoelastic

Manufacturer:

MAXIGEN BIOTECH INC.,

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 12, 2024

TECNIS Synergy™ OptiBlue™ IOL

Manufacturer:

AMO GRONINGEN B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 8, 2024

ROSSMAX Pulse Oximeter

Manufacturer:

ROSSMAX INNOTEK CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

TECNIS Synergy™ OptiBlue™ IOL

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 8, 2024

AIDIAN Uricult

Manufacturer:

AIDIAN LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 8, 2024

TECNIS Synergy™ Toric II OptiBlue™ IOL with TECNIS SIMPLICITY ™ Delivery System

Manufacturer:

AMO GRONINGEN B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 8, 2024

TECNIS Synergy™ Toric II OptiBlue™ IOL with TECNIS SIMPLICITY ™ Delivery System

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 8, 2024

COMPACT INTUITIV System

Manufacturer:

AMO MANUFACTURING USA, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

ROSSMAX Pulse Oximeter

Manufacturer:

ROSSMAX INNOTEK CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2024

OIC DRPx Locking Distal Radius Plate System

Manufacturer:

ORTHO SOLUTIONS SDN BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2024

NOVA T 380

Manufacturer:

BAYER LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 7, 2024

A&D Digital Blood Pressure Monitor

Manufacturer:

A&D ELECTRONICS (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2024

BD MICRO-FINE ™ + Pen Needles

Manufacturer:

EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

BD Ultra-Fine ™ PRO

Manufacturer:

BECTON DICKINSON AND COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

STARDEC Non Rebreathing Mask

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2024

TECNIS Eyhance™ Toric II IOL with TECNIS SIMPLICITY™ Delivery System

Manufacturer:

AMO GRONINGEN B.V

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 9, 2024

TECNIS Eyhance™ Toric II IOL with TECNIS SIMPLICITY™ Delivery System

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

COOPDECH® Balloonjector®

Manufacturer:

DAIKEN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

CareBuddy HbA1c Test Cartridge

Manufacturer:

CAREFORU. CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

VERITAS ™ Vision System

Manufacturer:

AMO MANUFACTURING USA, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 28, 2024

COOPDECH Syrinjector 120

Manufacturer:

DAIKEN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

COOPDECH Syrinjector 60 Ambulatory Infusion Pump

Manufacturer:

DAIKEN MEDICAL CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

CareBuddy Multi Analyzer

Manufacturer:

CAREFORU. CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 18, 2024

THE UNFOLDER Platinum 1 Series Implantation System Handpiece

Manufacturer:

DUCKWORTH & KENT LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 12, 2024

NASALIN Daily Nasal Hygiene Microdiffusion

Manufacturer:

GILBERT LABORATORIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

QUIDEL TRIAGE MeterPro and Accessories

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2024

QUIDEL TRIAGE NT-proBNP Control 2

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2024

QUIKREAD go CRP Control Low

Manufacturer:

AIDIAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2024

QUIDEL TRIAGE Profiler SOB™ Panel

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2024

QUIKREAD go wrCRP

Manufacturer:

AIDIAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2024

QUIDEL TRIAGE D-Dimer Test

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 9, 2024

QUIDEL TRIAGE NT-proBNP Test

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 9, 2024

LABCHOICE Conical Tube

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 17, 2023

WELL LEAD Laryngeal Mask Device

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

QuikRead go HbA1c Control Set

Manufacturer:

AIDIAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

STARDEC Nasal Oxygen Cannula

Manufacturer:

WELL LEAD MEDICAL CO. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 21, 2023

QuikRead go iFOBT Control Quantitative

Manufacturer:

AIDIAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2023

QuikRead go iFOBT

Manufacturer:

AIDIAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

STYPCEL™ Absorbable Hemostat

Manufacturer:

MEDPRIN REGENERATIVE MEDICAL TECHNOLOGIES CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 25, 2023

STARDEC Oxygen Mask

Manufacturer:

WELL LEAD MEDICAL CO. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 6, 2023

QuikRead go CRP Control

Manufacturer:

AIDIAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2023

QuikRead Go HbA1c

Manufacturer:

AIDIAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2023

QuikRead go CRP

Manufacturer:

AIDIAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

STARDEC DecaPlast Waterproof

Manufacturer:

PHARMACARE LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 29, 2023

VTEK Automatic Reusable Biopsy Device

Manufacturer:

VIGEO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

REDURA (Regenerative Dural Repair Patch)

Manufacturer:

MEDPRIN REGENERATIVE MEDICAL TECHNOLOGIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2023

LABCHOICE DecaBio GH82 Blood Glucose Test Strip

Manufacturer:

TIANJIN EMPECS MEDICAL DEVICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2023

AUTOCUT P Biopsy Needle

Manufacturer:

VIGEO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

Ceveron m4

Manufacturer:

TECO MEDICAL INSTRUMENTS, PRODUCTION + TRADING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2023

Ceveron m2

Manufacturer:

TECO MEDICAL INSTRUMENTS, PRODUCTION + TRADING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2023

STARDEC DecaPlast Kain Elastis

Manufacturer:

PHARMACARE LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2023

STARDEC DecaPlast Character, Zoo Party

Manufacturer:

PHARMACARE LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2023

MYELO SLIM

Manufacturer:

VIGEO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2023

ERGO Bone Marrow Aspiration Needle

Manufacturer:

VIGEO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2023

LABCHOICE DecaBio GH82 Blood Glucose Monitoring System

Manufacturer:

TIANJIN EMPECS MEDICAL DEVICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 18, 2023

CEVERON m1

Manufacturer:

TECO MEDICAL INSTRUMENTS, PRODUCTION + TRADING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2023

OPTILUBE Active, Sterile Lubricating Jelly

Manufacturer:

ISTEM MEDIKAL MEDIKAL DEVICE AND INDUSTRY CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2023

OPTILUBE Sterile Lubricating Jelly

Manufacturer:

JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

OPTILUBE Active CHG Free, Sterile Lubricating Jelly

Manufacturer:

ISTEM MEDIKAL MEDIKAL DEVICE AND INDUSTRY CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2023

LABCHOICE Drug Abuse Test, Multi 7

Manufacturer:

PROMETHEUS BIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 20, 2023

LABCHOICE Drug Abuse Test, Multi 3

Manufacturer:

PROMETHEUS BIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 20, 2023

TOP GLOVE Nitrile Examination Gloves, Powder Free

Manufacturer:

TOP GLOVE SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

TOP GLOVE Sterile Latex Surgical Gloves, Powder Free

Manufacturer:

TG MEDICAL SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

TOP GLOVE Latex Examination Gloves, Powder Free

Manufacturer:

TOP GLOVE SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

TOP GLOVE Latex Examination Gloves, Powdered

Manufacturer:

TOP GLOVE SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

TOP GLOVE Sterile Latex Surgical Gloves, Powdered

Manufacturer:

TG MEDICAL SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 12, 2022

QUIDEL TriageTrue High Sensitivity Troponin I Control 1

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2022

QUIDEL TriageTrue High Sensitivity Troponin I Control 2

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

QUIDEL TriageTrue High Sensitivity Troponin I Test

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

BALTON Large vessel catheterization kits triple lumen

Manufacturer:

BALTON SP. From O.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 15, 2022

BALTON Vessel Catheterization Catheter and Kits Double Lumen

Manufacturer:

BALTON SP. From O.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 10, 2022

EPILONG Kit

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

PAJUNK Radiofrequency Thermolesion Cannula (RFTL)

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

SPROTTE® Cannula

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

DELTACUT Biopsy

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2022

STARDEC Nitrile Examination Glove

Manufacturer:

TOP GLOVE SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

NASALIN Baby Daily Nasal Hygiene Microdiffusion

Manufacturer:

GILBERT LABORATORIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 1, 2022

GensuPen 2

Manufacturer:

BIOTON S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2022

WELL LEAD Oxygen Mask

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 15, 2022

WELL LEAD Nebulizer with Mask and 7 ft Tubing

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2022

WELL LEAD Nebulizer with Tee, Tubing and Mouthpiece

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2022

WELL LEAD Suction Tubes of Oral Care

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2022

WELL LEAD Nasal Oxygen Cannula

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 31, 2022

ANYSAFE + UNIVERSAL Drape (Laparoscopy)

Manufacturer:

MEDIPROTEK VIETNAM CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

ANYSAFE + UNIVERSAL Set Standard

Manufacturer:

MEDIPROTEK VIETNAM CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2021

STARDEC Non Rebreathing Mask

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 20, 2021

SOVEREIGN Compact Console

Manufacturer:

AMO MANUFACTURING USA, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2021

LipiFlow® Thermal Pulsation System

Manufacturer:

SPARTRONICS STRONGSVILLE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2021

MEIBOMIAN Gland Evaluator

Manufacturer:

REMINGTON MEDICAL, S.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 1, 2021

LipiScan™ Dynamic Meibomian Imager

Manufacturer:

SPARTRONICS STRONGSVILLE, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 23, 2021

MEIBOMIAN Gland Evaluator

Manufacturer:

SPARTRONICS STRONGSVILLE, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 23, 2021

H3-Check Normal

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

H3/5-Hypoclean

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 9, 2021

TECNIS Synergy ™ OptiBlue ™ IOL with TECNIS Simplicity ™ Delivery System

Manufacturer:

AMO GRONINGEN B.V

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 9, 2021

TECNIS Eyhance ™ Toric II IOL

Manufacturer:

AMO PUERTO RICO MANUFACTURING, INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 1, 2021

H3-Check Complete

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

H3-Compact 500

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 21, 2021

H3-Compact 100

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 21, 2021

PLEXOLONG NanoLine acc. Meier

Manufacturer:

PAJUNK MEDIZINTECHNOLOGIE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 4, 2021

DELTACUT Gun

Manufacturer:

PAJUNK MEDIZINTECHNOLOGIE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2021

INTRALONG Kit

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2021

TROKACUT

Manufacturer:

PAJUNK MEDIZINTECHNOLOGIE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2021

TROKABONE

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2021

PAJUNK Uniplex Nanoline

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2021

PAJUNK SonoPlex Stim Cannula

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2021

PAJUNK Thermolesion Cannula

Manufacturer:

PAJUNK GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2021

MULTISET UPK Nanoline

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2021

PAJUNK SonoTap Cannula

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2021

PAJUNK PrimoCut

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2021

PAJUNK Infiltralong

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 28, 2021

TECHNOCLONE Ca-Chloride Solution

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

EpiSpin Lock

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 13, 2021

TECHNOCLONE Coagulation Control A

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

TC Coagulation Control AK

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

HEMOLOK Gel

Manufacturer:

THEMIS MEDICARE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2020

PAJUNK Plexolong

Manufacturer:

PAJUNK GMBH MEDIZINTECHNOLOGIE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2020

TECHNOCLONE Imidazole Buffer

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2020

TC Coagulation Control N

Manufacturer:

TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

WELL LEAD Salvus Laryngeal Mask Device

Manufacturer:

WELL LEAD MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2020

WELL LEAD Qsafe Laryngeal Mask Device

Manufacturer:

WELL LEAD MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2020

COVIDIEN GENIUS 3 Tympanic Thermometer and Base

Manufacturer:

COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2020

PARKER FLEX-IT™ Stylet

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2020

STARDEC Suction Catheter

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2020

CM-300 Ultrasound Bone Densitometer

Manufacturer:

FURUNO ELECTRIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2020

ROSSMAX Pulse Oximeter

Manufacturer:

ROSSMAX INNOTEK CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2020

HEMOLYZER 5 NG Hematology Analyzer (Open Mode)

Manufacturer:

NORMA INSTRUMENTS ZRT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

HEMOLYZER 5 NG Hematology Analyzer (closed mode)

Manufacturer:

NORMA INSTRUMENTS ZRT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

QUIDEL TRIAGE MeterPro and Accessories

Manufacturer:

QUIDEL CARDIOVASCULAR INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2019

BIOLYZER FLUITEST GPT ALT

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2019

HEMOLYZER-5-Lyser

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2019

BIOLYZER TURBITEX CRP Latex

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2019

BIOLYZER FLUITEST GLU HK

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2019

HEMOLYZER 5 Control (L,N,H)

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2019

HEMOLYZER-5-Diff 5P

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2019

BIOLYZER CONTROPATH Plus

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2019

HEMOLYZER Diluent

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2019

HEMOLYZER-3-Lyser

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2019

HEMOLYZER-3-Control Normal

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2019

HEMOLYZER-3-Cleaner

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 25, 2019

HEMOLYZER Hypocleaner

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 25, 2019

BIOLYZER BIO CAL E

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 25, 2019

HEMOLYZER-5-Control Normal

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 25, 2019

BIOLYZER Wash Solution C-1

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 25, 2019

BIOLYZER Wash Solution 2

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2019

BIOLYZER CONTROPATH L

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2019

BIOLYZER Turbitex HbA1c

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2019

Hemolyzer 5 and Accessories

Manufacturer:

DIATRON MI PLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2019

BIOLYZER Serum Control CK, CK-MB

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2019

BIOLYZER Urine Control Set

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2019

BIOLYZER Fluitest TP

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2019

HEMOLYZER 3 Pro and Accessories

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2019

BIOLYZER CONTRONORM Plus

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2019

BIOLYZER Bio Cal L

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2019

BIOLYZER Bio Cal Spesific Enzymes

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2019

BIOLYZER FLUITEST TG

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2019

BIOLYZER 600 Clinical Chemistry Analyzer and Accessories

Manufacturer:

FURUNO ELECTRIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2019

BIOLYZER Fluitest® GLU

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 23, 2019

BIOLYZER FLUITEST UA

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2019

BIOLYZER Precision Check

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2019

BIOLYZER 300 Clinical Chemistry Analyzer and Accesssories

Manufacturer:

FURUNO ELECTRIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2019

BIOLYZER FLUITEST HDL direct

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2019

BIOLYZER FLUITEST LDL Direct

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2019

BIOLYZER Fluitest CREA PAP

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2019

BIOLYZER FLUITEST® CREATES

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2019

BIOLYZER FLUITEST GOT AST

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2019

BIOLYZER FLUITEST CHOL

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2019

BIOLYZER Fluitest ALB BCG

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2019

BIOLYZER FLUITEST ALP IFCC

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2019

BIOLYZER Whistle Est LDH-L

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2019

BIOLYZER Fluitest LIP Col.

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2019

BIOLYZER Whistle AMYL IFCC

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2019

BIOLYZER TURBITEX DO

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2019

BIOLYZER FLUITEST MG XB

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2019

BIOLYZER Fluitest BIL Total

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2019

BIOLYZER Fluitest BIL Direct

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2019

BIOLYZER Whistle Gusto GGT

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2019

BIOLYZER Whistle CK-MB

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2019

HEMOLYZER-3-Control Set

Manufacturer:

ANALYTICON BIOTECNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2019

BIOLYZER FLUITEST CA CPC

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2019

BIOLYZER WHISTLES Urea

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2019

BIOLYZER Wash Solution 1

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 28, 2019

FLUITEST PHOS

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2019

BIOLYZER Fluitest FE FZ

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 20, 2019

BIOLYZER Diluent

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 14, 2019

BIOLYZER Fluitest CK-NAc

Manufacturer:

ANALYTICON BIOTECHNOLOGIES AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2019

FURUNO Ultrasound Bone Densitometer

Manufacturer:

FURUNO ELECTRIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2018

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

Last updated: December 2025