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PT. SURGIKA ALKESINDO

Authorized Representative in Indonesia

Jl. Letjen Suprapto No.60, Gedung Indra Sentral unit G-H, Cempaka Putih
384 Products Represented
137 Manufacturers
Total Products
384
Manufacturers
137
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
91 products
23.7%
Kelas Resiko : B
202 products
52.6%
Kelas Resiko : C
73 products
19.0%
Kelas Resiko : D
18 products
4.7%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (384)
Complete portfolio registered with BPOM

IDS Fractional CO2 Laser

Manufacturer:

IDS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

NOPA Neuro Surgery Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2025

HAAG-STREIT Operating Microscope

Manufacturer:

HAAG-STREIT AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2025

SCHMITZ Examination and Treatment Chair Arco

Manufacturer:

SCHMITZ MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

HYDROCYN aqua Solution

Manufacturer:

BACTIGUARD (SOUTH EAST ASIA) SDN.BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2025

RADIOBLATOR RF4

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

HYDROCYN Aqua Wound Prep Absorbent Gauze

Manufacturer:

BACTIGUARD (SOUTH EAST ASIA) SDN.BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 17, 2025

IDS Picosecond Nd:YAG Laser

Manufacturer:

IDS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2025

ATMOS ENT Treatment System

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 2, 2025

NOPA Pediatric Surgery Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 2, 2025

RICHARD WOLF PANOVIEW Telescope

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

ERAGON Modular and Axial

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

APC 3 Argon Plasma Coagulation

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

UFSK Treatment Chair eyeForce

Manufacturer:

UFSK-INTERNATIONAL OSYS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2024

REICHERT TF50 Trial Frame

Manufacturer:

LIANYUNGANG TIANNUO OPTICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2024

REICHERT TS75 Trial Lens Set

Manufacturer:

LIANYUNGANG TIANNUO OPTICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2024

VIO 3 Electrosurgical unit

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2024

GEUDER SOLEA LED Light Source

Manufacturer:

GEUDER AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 4, 2024

MEDTRON ACCUTRON HP

Manufacturer:

MEDTRON AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2024

PIEZOWAVE 2 Control Unit

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2024

ERBEJET 2 Hydrosurgical Unit

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2024

OPTOCHEK Plus Auto Refractor / Keratometer

Manufacturer:

REXXAM. CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 21, 2024

PIEZOWAVE 2 CONTROL UNIT

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2024

LITHOTRIPTER 3000

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 12, 2024

MEGATRON S4 Ophthalmic Surgical System

Manufacturer:

GEUDER AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 9, 2024

TUTTNAUER Washer Disinfectors

Manufacturer:

TUTTNAUER EUROPE B. V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

NOPA General Surgery Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 6, 2024

VITAL-CATH 72 Plus Closed Suction System

Manufacturer:

VITALTEC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

UFSK Surgeon's Chair surgiForce, with Formed Seat

Manufacturer:

UFSK-INTERNATIONAL OSYS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 22, 2024

ATRASORB Pharma Pink

Manufacturer:

ATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2024

EMS LaserClast TM Fiber

Manufacturer:

QUANTA SYSTEM S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

PROFEEL Lightly Powdered NR Latex Surgical Gloves

Manufacturer:

WRP ASIA PACIFIC SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2024

ATRASORB Pharma

Manufacturer:

ATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2024

KLS MARTIN independant Flex S

Manufacturer:

L.M. MEDICAL DIVISION SRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

KLS MARTIN independant Fix Wall

Manufacturer:

L.M. MEDICAL DIVISION SRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

KLS MARTIN independant Fix Ceiling

Manufacturer:

L.M. MEDICAL DIVISION SRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

KLS MARTIN Independant Fix Bridge

Manufacturer:

L.M. MEDICAL DIVISION SRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

KLS MARTIN Independant Care Horizontal ES

Manufacturer:

L.M. MEDICAL DIVISION SRL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

KLS MARTIN independant Flex M

Manufacturer:

L.M. MEDICAL DIVISION SRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

BI-FLEX Aspheric Hydrophilic Acrylic IOL

Manufacturer:

MEDICONTUR MEDICAL ENGINEERING LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2024

MEDICONTUR BI-FLEX HB Aspheric Hydrophobic Acrylic IOL

Manufacturer:

MEDICONTUR MEDICAL ENGINEERING LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 1, 2024

SCHARIOTH MACULAR Lens

Manufacturer:

MEDICONTUR MEDICAL ENGINEERING LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 27, 2024

MEDICONTUR Bi-FLEX POB-MA Aspheric Hydrophobic Acrylic IOL

Manufacturer:

MEDICONTUR MEDICAL ENGINEERING LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 27, 2024

MEDICONTUR TRIFOCAL Bi-Flex Liberty

Manufacturer:

MEDICONTUR MEDICAL ENGINEERING LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 27, 2024

MEDICONTUR Aspheric Hydrophobic Acrylic IOL

Manufacturer:

MEDICONTUR MEDICAL ENGINEERING LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 27, 2024

LEISEGANG Colposcope

Manufacturer:

LEISEGANG FEINMECHANIK-OPTIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2024

HEINE Dermatoscope

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2024

NOPA Gynecology & Obstretical Instruments Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 20, 2024

MEDICONTUR Disposable Injection Kit

Manufacturer:

MDJ SAS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 17, 2024

MEDICONTUR Disposable Injection Kit

Manufacturer:

MDJ SAS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 17, 2024

MEDICONTUR Classic Aspheric Hydrophilic Acrylic IOL

Manufacturer:

MEDICONTUR MEDICAL ENGINEERING LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 10, 2024

RICHARD WOLF Resectoscope Set

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2024

SCIENCEMEDIC Dynamic Z Medical Handpiece with Accessory

Manufacturer:

SCIENCEMEDIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

WECK HEM-O-LOK Ligating Clips

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE R.L DE C.V. (A Teleflex Medical Company)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 22, 2024

NEUSOFT Medical Angiography X-ray System

Manufacturer:

NEUSOFT MEDICAL SYSTEMS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2024

NEUSOFT Medical Angiography X-ray System

Manufacturer:

NEUSOFT MEDICAL SYSTEMS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 20, 2024

PILLING Microvascular Anastomosis and Vascular instrument Set

Manufacturer:

TELEFLEX MEDICAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

SCHMITZ Examination and Treatment Chair Arco-matic

Manufacturer:

SCHMITZ U. SOHNE GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

TELEFLEX Weckstat Staple Remover

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V (A TELEFLEX MEDICAL COMPANY)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

BI-FLEX ELON Toric POB-MA Hydrophobic Preloaded IOL

Manufacturer:

MEDICONTUR MEDICAL ENGINEERING LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 12, 2024

VERSACUT Tissue Morcellator

Manufacturer:

LUMENIS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

HAAG-STREIT Operating Microscope

Manufacturer:

HAAG-STREIT AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 22, 2024

VERSIUS Surgical System

Manufacturer:

CMR SURGICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 10, 2024

LUMENIS Pulse 100H

Manufacturer:

LUMENIS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

TONO-PEN AVIA® Tonometer

Manufacturer:

REICHERT INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2024

VISISTAT Skin Stapler

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V. (A TELEFLEX MEDICAL COMPANY)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

FOXTROT PRO PTCA Balloon Catheter

Manufacturer:

SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD. (NEWTON)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 21, 2024

TERRAGENE® Biological Indicator

Manufacturer:

TERRAGENE S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2024

CLEARCHART 4 Digital Acuity System

Manufacturer:

REICHERT INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2024

ATMOS C31 Economy ENT Workstation

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2024

TERRAGENE® Bowie & Dick Test Pack

Manufacturer:

TERRAGENE S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

TERRAGENE® Chemical Indicator

Manufacturer:

TERRAGENE S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

PRIMEDIC HeartSave AED

Manufacturer:

METRAX GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

PRIMEDIC ™ HeartSave AS Automatic Defibrillator

Manufacturer:

METRAX GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

PRIMEDIC DefiMonitor XD30

Manufacturer:

METRAX GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

PRIMEDIC HeartSave AED-M

Manufacturer:

METRAX GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

FOXTROT NC PTCA Balloon Catheter

Manufacturer:

SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2024

RICHARD WOLF ENDOCAM Flex HD

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

RICHARD WOLF Uretero- Renoscope Instrument Set

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

PRIMEDIC™ DefiMonitor XD330xe (M290)

Manufacturer:

METRAX GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 9, 2024

PRIMEDIC DefiMonitor XD1

Manufacturer:

METRAX GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 9, 2024

RICHARD WOLF ENDOCAM Logic HD

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

PRIMEDIC DefiMonitor XD330

Manufacturer:

METRAX GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

RICHARD WOLF Hysterescope Instrument Set

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

RICHARD WOLF Percutaneous Universal Nephroscope (PCN)

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

RICHARD WOLF Laparoscopy Instrument Set

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

PIEZOWAVE 2 CONTROL UNIT

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

HEINE DELTA 20 T Dermatoscope

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

RICHARD WOLF Tower 4K 55 for Arthroscopy

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

RICHARD WOLF Tower 4K 31 for Arthroscopy

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

RICHARD WOLF Cysto - Uretroscope

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

PRUNUS Ventilator

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 28, 2024

DS MAREF Digital Pneumatic Torniquet System

Manufacturer:

DAESUNG MAREF CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

PRUNUS Ventilator

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 27, 2024

USHIO TheraBeam UV308 Slim

Manufacturer:

USHIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

PIRANHA Suction Pump Tissue Morcellator

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

TELEFLEX PILLING Punch Aorta

Manufacturer:

TELEFLEX MEDICAL OF MEXICO. S. DE R.L DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 14, 2024

ERAGONstitch Needle Holders

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

RICHARD WOLF Flexible Bronschoscope

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 12, 2024

CUSA Excel Ultrasonic Surgical Aspirator System

Manufacturer:

INTEGRA LIFESCIENCES (IRELAND) LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 14, 2024

BODYTOM 64 NL4100 Computed Tomography X-ray System

Manufacturer:

NEUROLOGICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 11, 2024

INSIGHTERS Video Laryngoscope

Manufacturer:

SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2024

TELEFLEX PILLING Pediatric Surgery Standard Set

Manufacturer:

TELEFLEX MEDICAL (MORRISVILLE).

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 9, 2024

INSIGHTERS Video Laryngoscope

Manufacturer:

SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2024

WECK VISTA Laparoscopic Access Stability Ports (Ribbed)

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE. R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2024

COMFIT Premium Powdered Latex Surgical Gloves

Manufacturer:

WRP ASIA PACIFIC SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 8, 2024

TELEFLEX Minilap Percutaneous Surgical System

Manufacturer:

LACEY MANUFACTURING CO., LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2024

WECK Vista Ballon Open Access Port

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE. R.L. DE C.V. (A TELEFLEX MEDICAL COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2024

PROFEEL DHD Extra Protection Powder Free Latex Surgical Gloves

Manufacturer:

WRP ASIA PACIFIC SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 4, 2024

PLEUR-EVAC A-7000 Rain Series

Manufacturer:

TELEFLEX MEDICAL DE MEXICO S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

PILLING CABG (Coronary) Instrument Set

Manufacturer:

TELEFLEX MEDICAL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 3, 2024

INSIGHTERS Video Laryngoscope

Manufacturer:

SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 29, 2023

TELEFLEX Weck Vista Laparoscopic Access Optical Entry Ports

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE. R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

GEUDER Ophthalmic Surgery Instruments 4

Manufacturer:

GEUDER AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 28, 2023

TELEFLEX PILLING Basic Set Cardiac Surgery

Manufacturer:

TELEFLEX MEDICAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 28, 2023

PILLING Paediatric Surgery Set

Manufacturer:

TELEFLEX MEDICAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 27, 2023

PILLING Adult Instrument Set

Manufacturer:

TELEFLEX MEDICAL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 22, 2023

PILLING Retractor Set

Manufacturer:

TELEFLEX MEDICAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 22, 2023

GABBAY FRATER Suture Guide

Manufacturer:

TELEFLEX MEDICAL DE MEXICO, S. DE R.L. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 21, 2023

PLEUR-EVAC A-8000 Rain Series

Manufacturer:

TELEFLEX MEDICAL DE MEXICO S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2023

MINIPOLAR Electrosurgery Probes

Manufacturer:

LACEY MANUFACTURING CO., LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2023

WECK Hem-O-Lok Ligating Clip Appliers/Remover

Manufacturer:

TECOMET, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2023

WECK Horizon Ligating Clip Appliers

Manufacturer:

TECOMET INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 18, 2023

WECK Automatic HEM-O-LOK Clip Applier

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE. R.L. DE C.V. (A TELEFLEX MEDICAL COMPANY)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2023

WECK Horizon Ligating Clips

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

WECK HEM-O-LOK Ligating Open Applier

Manufacturer:

TECOMET, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2023

WECK HEM-O-LOK Ligaling Clip Appliers/Removers

Manufacturer:

TECOMET, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2023

BICAKCILAR Umbilical Catheter

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2023

RICHARD WOLF Endocam Logic 4K System

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2023

BICAKCILAR Suction Connecting Tube with Standard Connector

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SAN VE TIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2023

BICAKCILAR Reinforced Tracheal Tube, Uncuffed

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2023

BICAKCILAR Tracheostomy Tube Uncuffed

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2023

BICAKCILAR Reinforced Tracheal Tube Cuffed

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

BICAKCILAR Tracheal Tube Murphy

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

BICAKCILAR Suction Catheter

Manufacturer:

BıÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

BICAKCILAR Trachea Suction Set, Funnel/Kapkon Connector

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

BICAKCILAR Rectal Tube

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SAN VE TIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

BICAKCILAR Nasogastric Catheter

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SAN VE TIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

Firefighter™ NC PTCA Balloon Catheter

Manufacturer:

SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

BICAKCILAR Tracheal Tube Murphy

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

BICAKCILAR Intubation Stylus

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

BICAKCILAR Thoracic Catheter

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

BICAKCILAR Feeding Tube

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SAN VE TIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

BICAKCILAR Guedel Airway

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SAN VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

BICAKCILAR Tracheostomy Tube with Cuff

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

FIREBIRD2 Rapamycin Eluting Coronary CoCr Stent System

Manufacturer:

SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 25, 2023

BICAKCILAR Extension Line with Three Way Stopcock

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2023

BICAKCILAR Thoracic Catheter with Trocar

Manufacturer:

BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2023

ERBE VIO 300 S Electrosurgery

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

ERBE Suction Module

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

ERBE VIO 200 S Electrosurgery

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

IES 3 Smoke Evacuation Unit

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2023

ERBE VIO 300 D Electrosurgery

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2023

ERBE VIO 50 C Electrosurgery

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2023

ERBECRYO 2 Cryosurgical Unit

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

ERBE VIO 200 D Electrosurgery Unit

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2023

ERBE VIO 100 C Electrosurgery

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2023

ERBE EIP 2 Irrigation Pump

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2023

GEUDER Endotron 532 nm Surgical System

Manufacturer:

GEUDER AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2023

APC 2 (for VIO ) Argon Plasma Coagulation

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

MEDILAND Hyper Light Disinfection Robot

Manufacturer:

MEDILAND ENTERPRISE CORPORATION LINKOU FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2023

UFSK Treatment Chair 500 XLE Comfort

Manufacturer:

UFSK INTERNATIONAL OSYS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2023

TERRAGENE CHEMDYE Chemical Multi-variable Indicator

Manufacturer:

TERRAGENE S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

TERRAGENE BIONOVA Biological Indicator

Manufacturer:

TERRAGENE S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

TERRAGENE CINNTAPE Chemical Process Indicator Tape

Manufacturer:

TERRAGENE S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

RICHARD WOLF Laser Surgery Device Tower 70W

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2023

CGM Elegance Electric Bed

Manufacturer:

CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2023

DIAMOND 60 BLK Universal Operating Table

Manufacturer:

SCHMITZ U. SOHNE GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2023

CHANG GUNG Hydraulic Stretcher

Manufacturer:

CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2023

Evidence MULTISTAT

Manufacturer:

RANDOX LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2023

OMNITOM Elite NL5000 Computed Tomography X-ray System

Manufacturer:

NEUROLOGICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 27, 2023

PRUNUS Air Compressor

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2023

BodyTom Elite NL4000 Computed Tomography X-ray System

Manufacturer:

NEUROLOGICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2023

PRUNUS BOARAY 1000D Emergency and Transport Ventilator

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2023

PRUNUS BOARAY 5000D Ventilator

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2023

GEUDER Ophthalmic Surgery Instruments

Manufacturer:

GEUDER AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 5, 2023

GEUDER Opthalmic Vitrectomy Surgery Instruments

Manufacturer:

GEUDER AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 30, 2023

DENSIRON Xtra

Manufacturer:

FLUORON GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2023

GEUDER Ophthalmic Surgery Instruments 6

Manufacturer:

GEUDER AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 25, 2023

HUREV OxiPulse SpO2 Sensor

Manufacturer:

HUREV CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

EZYPRO ECG Recorder

Manufacturer:

ACME PORTABLE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2023

TRIMAX TX55 Laser Imaging System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2023

NU-TEK Ultrasonic Physiotherapy Device

Manufacturer:

SHENZHEN DONGDIXIN TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2023

EZYPRO ECG Recorder

Manufacturer:

ACME PORTABLE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2023

NU-TEK ShortRehab Device

Manufacturer:

SHENZHEN DONGDIXIN TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2023

TRIMAX TX40 Laser Imaging System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2023

NU-TEK Ultrasound and Electrical Neuromuscular Stimulator

Manufacturer:

SHENZHEN DONGDIXIN TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2023

NU-TEK Ultrasound and Electrical Neuromuscular Stimulator

Manufacturer:

SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

TRIMAX TX65 Laser Imaging System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2023

TRIMAX CR System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

TRIMAX TXE Laser Imaging Film

Manufacturer:

RAYCO (XIAMEN) MEDICAL PRODUCTS CO. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 24, 2023

CUSA EXCEL and Ultrasonic Tissue Ablation System

Manufacturer:

INTEGRA LIFESCIENCES (IRELAND) LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2023

NU-TEK Ultrasound Physical Therapy Device

Manufacturer:

SHENZHEN DONGDIXIN TECHNOLOGY CO.,LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2023

TUTTNAUER GS Line Hospital Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2023

NU-TEK Electrical Neuromuscular Stimulator

Manufacturer:

SHENZHEN DONGDIXIN TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2023

NU-TEK Ultrasound & Electrical Combined Therapy Stimulator

Manufacturer:

SHENZHEN DONGDIXIN TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2023

TUTTNAUER Sterilization & Infection Control Product

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2023

TUTTNAUER Sterilization & Infection Control Product

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

RICHARD WOLF Power Drive ART1 2304

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

TUTTNAUER Plazmax Sterilizing Agent (H2O2)

Manufacturer:

TUTTNAUER EUROPE B. V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

SUMI Tracheal Tube with Low Pressure Cuff, Murphy, Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

TUTTNAUER PlazMax Line Low Temperature Sterilizer

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

TUTTNAUER Automatic Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

TUTTNAUER Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

TUTTNAUER Steam Sterilizer

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

TUTTNAUER Automatic Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

TUTTNAUER Automatic Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

TUTTNAUER Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

TUTTNAUER Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

SUMI Reinforced Laryngeal Mask Airway

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP.K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

TUTTNAUER Automatic Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

SUMI Laryngeal Mask Airway

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP.K.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 23, 2022

TUTTNAUER Large Hospital Sterilizer

Manufacturer:

TUTTNAUER EUROPE B.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2022

TUTTNAUER Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2022

TUTTNAUER PLAZMAX Line Low Temperature Sterilizer

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2022

TUTTNAUER Large Hospital Sterilizer

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2022

SUMI Laryngeal Mask Airway

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP.K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

TUTTNAUER Large Hospital Sterilizer

Manufacturer:

TUTTNAUER EUROPE B.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

TUTTNAUER Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

SUMI Reinforced Tracheal Tube without Cuff, Murphy, Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP. K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2022

SUMI Tracheostomy Tubes KAN with Cuff, Fenestrated

Manufacturer:

SUMI SPÓŁKA Z ORGANICZONA ODPOWIEDZIALNOŚCIĄ SP, K

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2022

SUMI Reinforced Tracheal Tube with Cuff, Murphy, Siliconised, with Stylet

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP. K

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2022

TUTTNAUER Autoclave

Manufacturer:

TUTTNAUER EUROPE B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2022

SUMI Tracheostomy Tube with Low Pressure Cuff, Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2022

SUMI Double Lumen Bronchial Tube, Siliconised

Manufacturer:

SUMI SPÓŁKA Z ORGANICZONA ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2022

SUMI Tracheostomy Tube without Cuff, Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2022

SUMI Tracheostomy Tube KAN without Cuff

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

SUMI Tracheal Tube without Cuff, Murphy, Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

SUMI Tracheal Tube with Suction Lumen, Murphy

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

SUMI Tracheal Tube with Low Pressure Cuff Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

SUMI Guedel Airway

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

SUMI Reinforced Tracheal Tube with Cuff, Murphy, Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP, K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

SUMI KAN Tracheostomy Tube with Cuff

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP.K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

SUMI Preformed Tracheal Tube without Cuff Oral Murphy Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP.. K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

SUMI Preformed Tracheal Tube with Cuff Oral Murphy Siliconised

Manufacturer:

SUMI SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ SP. .K.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

PAKION Sterilization Gusseted Reel

Manufacturer:

JIANGSU PAKION MEDICAL MATERIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2022

SUMI Tracheal Tube Introducers Reuseable

Manufacturer:

SUMI SPÓŁKA Z ORGANICZONA ODPOWIEDZIALNOŚCIĄ SP, K

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2022

RICHARD WOLF Arthroscopy Instruments Set 2

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2022

RICHARD WOLF Arthroscopy Instruments Set

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2022

PAKION Crepe Paper

Manufacturer:

JIANGSU PAKION MEDICAL MATERIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2022

RICHARD WOLF ENDOCAM Logic HD Lite Controller

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

RICHARD WOLF Flexible Naso-Pharyngo-Laryngoscope

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

RICHARD WOLF Urethrotome Set

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2022

RICHARD WOLF Endocam Performance HD 5514

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2022

RICHARD WOLF INSUFFLATOR Highflow 45 EVAC

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

RICHARD WOLF INSUFFLATOR Highflow 45 HEAT Set

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

RICHARD WOLF Endocam Epic 3DHD

Manufacturer:

RICHARD WOLF GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2022

RICHARD WOLF INSUFFLATOR Highflow 45 EVAC + HEAT Set

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2022

RICHARD WOLF INSUFFLATOR Highflow 45 BASIC Set

Manufacturer:

RICHARD WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2022

KLS Martin Operation Light

Manufacturer:

KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

MEDILAND Hyper Light Disinfection Robot

Manufacturer:

MEDILAND ENTERPRISE CORPORATION LINKOU FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2022

EGEMEN Spinal Needle

Manufacturer:

TMT TIBBI MEDIKAL MALZEME SAN. VE TIC. AS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2022

KLS MARTIN Operation Light marLED E15

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2022

EGEMEN Epidural Needle

Manufacturer:

TMT TIBBI MEDIKAL MALZEME SAN. VE TIC. AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2022

KLS MARTIN Operation Light marLED E9i

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2022

KLS MARTIN Examination Light marLED E1

Manufacturer:

DERUNGS LICHT AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 28, 2022

ALTECH Proximal Pressure Line Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2022

ALTECH Adult Oxygen Mask

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 7, 2022

ALTECH Mini Anti Bacterial Viral HME Filter

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

ALTECH Modified Jackson Reevess Circuits

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE T.S. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

ALTECH Breathing Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 1, 2022

ALTECH Neoprene Breathing Bag

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE T.S. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

ALTERA ALTECH Tracheostomy HME Filter

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

ALTECH Aerosol Therapy Set with Mouth Piece

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 1, 2022

ALTECH Aerosol Therapy Set

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

ALTECH Anesthesia Circuit With Limb Breathing Bag/Bacterial-Viral Filter

Manufacturer:

MEDITERA TIBBI MALZEME SAN VE TIC A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 1, 2022

ALTECH Adult Oxygen High Concentration Non-Rebreathing Mask (O2 Therapy Set)

Manufacturer:

MEDITERA TIBBI MALZEME SAN VE TIC A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 1, 2022

ALTECH Pediatric Oxygen Therapy Set with Re-Breathing Bag

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 31, 2022

FOXTROT PRO PTCA Balloon Catheter

Manufacturer:

SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2022

ALTECH Single Heated Wire Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 31, 2022

ALTECH Bacterial Viral HME Filter Neonatal

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE T.S. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ALTECH MEDI-FLOW Circuits with Extendible Limb, Breathing Bag, Bacterial - Viral Filter

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ALTERA ALTECH Tracheostomy HME with Oxygen Tubing

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ALTECH Medi-Flow Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2022

ALTECH Medi-Flow Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2022

ALTECH Breathing Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN VE TIC A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2022

ALTECH Anti Bacterial/Viral-HME Filter

Manufacturer:

MEDITERA TIBBI MALZEME SAN VE TIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

ALTECH Catheter Mount

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2022

ALTECH Catheter Mount

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2022

ALTECH Breathing Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2022

ALTECH Breathing Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN VE TIC A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2022

ALTECH Bacterial Viral HME Filter

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ALTECH Breathing Circuit

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 20, 2022

ALTECH Anesthesia Mask

Manufacturer:

FOREMOUNT ENTERPRISE CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 20, 2022

SHD Automatic Surgical Scrub Sink

Manufacturer:

SHD ITALIA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2022

ALTECH Anti Bacterial Viral Filter

Manufacturer:

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

PRISTINE Microdermabrasion System

Manufacturer:

VIORA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2022

SCHMITZ Examination and Treatment Chair Arco-matic

Manufacturer:

SCHMITZ U. SOHNE GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 2, 2022

VIORA REACTION

Manufacturer:

VIORA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2022

SCHMITZ DIAMOND Operating Table

Manufacturer:

SCHMITZ U. SOHNE GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

SCHMITZ DIAMOND Operating Table

Manufacturer:

SCHMITZ U. SOHNE GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

SCHMITZ MEDI-MATIC Obstetric Table

Manufacturer:

SCHMITZ U. SOHNE GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

SWISS LASERCLAST

Manufacturer:

QUANTA SYSTEM S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 15, 2022

OPX Mobilis Operating Tables

Manufacturer:

SCHMITZ U. SOHNE GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 13, 2022

HEINE Delta One

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2022

HEINE Delta 30 Dermatoscope

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2022

TERRAGENE PRO1 MICRO Hygiene Monitoring System

Manufacturer:

TERRAGENE S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2022

TERRAGENE MiniBio Auto-Reader

Manufacturer:

TERRAGENE S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

TERRAGENE Self-Contained Biological Indicator

Manufacturer:

TERRAGENE S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2022

Bionova Biological Indicator Incubator

Manufacturer:

TERRAGENE S.A.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 8, 2022

HEINE EL 3 LED Examination Light

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 19, 2022

HEINE F.O LED Laryngoscope Handle

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 19, 2022

HEINE Beta 200 S Ophthalmoscope

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2022

HEINE Flex Tip Laryngoscope

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2022

HEINE Mini 3000 LED Ophthalmoscope

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

HEINE Retinometer

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

HEINE Beta 200 Streak Retinoscope

Manufacturer:

HEINE OPTOTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

PAKION Self Sealing Pouch

Manufacturer:

JIANGSU PAKION MEDICAL MATERIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

PAKION Sterilization Flat Reel

Manufacturer:

JIANGSU PAKION MEDICAL MATERIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

PAKION Plasma Tyvek Reel

Manufacturer:

JIANGSU PAKION MEDICAL MATERIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 10, 2022

LEISEGANG LM-900 Cryosurgery System

Manufacturer:

COOPERSURGICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 7, 2022

HEMY® Tubing Sets for Hemodialysis

Manufacturer:

BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 29, 2022

HEMY® Disposable A.V. Fistula Needle Sets

Manufacturer:

BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 29, 2022

HEMY® Hollow Fiber Dialyzer

Manufacturer:

BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2022

HEMY® Hollow Fiber Dialyzer

Manufacturer:

BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2022

UFSK Surgeon's Stool SurgiLine

Manufacturer:

UFSK INTERNATIONAL OSYS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 21, 2022

CHANG GUNG Electric Stretcher

Manufacturer:

CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2022

BLUESTAR PLUS Non Invasive Face Mask Kit

Manufacturer:

KOO MEDICAL EQUIPMENT (SHANGHAI) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 31, 2021

ATMOS S 351 Natal

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2021

SENTINEX Smart Special Surgical Gown

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO., KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2021

SENTINEX PRO Special Surgical Gown

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2021

RAUCODRAPE PRO Cardiovascular Set

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

RAUCODRAPE Smart C-Section Set

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

RAUCODRAPE Smart Universal Set

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

SENTINEX Smart Standard Surgical Gown

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2021

RAUCODRAPE Smart Arthroscopy Set

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2021

SENTINEX PRO Standard Surgical Gown

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2021

RAUCODRAPE PRO Cranium Set

Manufacturer:

LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2021

ERBE IES 2 Smoke Evacuator

Manufacturer:

ERBE ELEKTROMEDIZIN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 12, 2021

CURIS Microsurgical Radiofrequency Generator

Manufacturer:

SUTTER MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 5, 2021

SUTTER Radiofrequency Generator

Manufacturer:

SUTTER MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 5, 2021

SUPERGLISS Bipolar Forceps

Manufacturer:

SUTTER MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2021

CALVIAN Bipolar Instrument

Manufacturer:

SUTTER MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 30, 2021

TO-BITE Bipolar Dissection Clamp Instrument

Manufacturer:

SUTTER MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 27, 2021

SUTTER Rigid Bipolar Electrode

Manufacturer:

SUTTER MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 27, 2021

SUTTER Monopolar Electrode Instrument

Manufacturer:

SUTTER MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 27, 2021

MEDICONTUR Disposable Injection Kit

Manufacturer:

MDJ SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2021

MEDICONTUR Disposable Injection Kit

Manufacturer:

MDJ SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2021

ATMOS E341 Battery Emergency Suction Pump

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

ATMOS Suction Pump

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2021

ATMOS Portable Suction Pump

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2021

ATMOS Chair Professional

Manufacturer:

GREINER GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 2, 2021

ATMOS Chair Comfort

Manufacturer:

GREINER GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 28, 2021

ATMOS A 161 Battery

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2021

ATMOS C341 Battery Emergency Suction Pump

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2021

ATMOS C 161 Battery

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2021

ATMOS Audiometri

Manufacturer:

ZEISBERG GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2021

ATMOS C 21 Economy ENT Workstations

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2021

ATMOS Portable Suction Pump

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2021

ATMOS Surgical Suction Unit

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2021

ATMOS ENT Treatment Cabinet

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2021

ATMOS Suction Unit

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2021

ATMOS Headlight LED

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH., & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2021

ATMOS Vacuum Cleaner

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2021

ATMOS Suction Pump

Manufacturer:

ATMOS MEDIZINTECHNIK GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2021

Thermo TK

Manufacturer:

ZIMMER MEDIZINSYSTEME GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 4, 2021

CGM Pediatric Electric Bed

Manufacturer:

CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2021

CGM Intensive Care Electric Bed

Manufacturer:

CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2021

CGM Classic Electric Bed

Manufacturer:

CHANG GUNG MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

CHANG GUNG Electric Hospital Bed

Manufacturer:

CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 16, 2021

FENTEX FESS (Functional Endoscopy Sinus Surgery)

Manufacturer:

FENTEX MEDICAL GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2020

ROOM emFieldPro

Manufacturer:

REMED CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2020

MEDIVEN PLUS

Manufacturer:

MEDI GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 11, 2019

MEDI Protect. St

Manufacturer:

MEDI GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 5, 2019

MEDI Spinomed IV

Manufacturer:

MEDI GMBH. & CO., KG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 5, 2019

MEDI Protect.4 OA

Manufacturer:

MEDI GMBH & CO. KG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 5, 2019

MEDI Protect Air ROM Walker

Manufacturer:

MEDI GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 5, 2019

MEDI Protect ROM Cool Short Knee Mobilizer

Manufacturer:

MEDI GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 5, 2019

MIDDLE Orthocox

Manufacturer:

MEDI GMBH., & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 5, 2019

GENUINE MEDIUM

Manufacturer:

MEDI GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

MEDI LUMBAMED BASIC

Manufacturer:

MEDI GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

MEDI Lumbamed Plus

Manufacturer:

MEDI GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

MEDI Lumbamed Stable

Manufacturer:

MEDI GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

MEDI Protect Ankle Air

Manufacturer:

MEDI GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

MEDIUM Lumbamed Disc

Manufacturer:

MEDI GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

LEVAMED MEDIUM

Manufacturer:

MEDI GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

DUOMED MEDIUM

Manufacturer:

MEDI GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

FENTEX HI-CAM 1CCD Digital Endoscopy Camera

Manufacturer:

FENTEX MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 11, 2019

FENTEX HD CAM 3CCD Digital Endoscopy Camera

Manufacturer:

FENTEX MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 11, 2019

FENTEX Xenon Light Sources 180W

Manufacturer:

FENTEX MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 11, 2019

FENTEX FESS (FUNCTIONAL ENDOSCOPY SINUS SURGERY) Instrument Set

Manufacturer:

FENTEXMEDICAL GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2019

FENTEX Instruments For Rhinology

Manufacturer:

FENTEX MEDICAL GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2019

FENTEXMEDICAL Instrument For Larynx Surgery, Broncho and Esophagoscopy

Manufacturer:

FENTEXMEDICAL GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2019

FENTEX Instruments for Otology

Manufacturer:

FENTEX MEDICAL GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2019

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

Last updated: December 2025