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PT. TRANSMEDIC INDONESIA

Authorized Representative in Indonesia

Perkantoran Menara Era Unit G-01 JL.Senen Raya No.135-137 RT 00 RW 00, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Senen, Kel. Senen
268 Products Represented
102 Manufacturers
Total Products
268
Manufacturers
102
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
10 products
3.7%
Kelas Resiko : B
93 products
34.7%
Kelas Resiko : C
88 products
32.8%
Kelas Resiko : D
77 products
28.7%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (268)
Complete portfolio registered with BPOM

SANYOU Spinal Rod System (Cervical) Implant

Manufacturer:

SHANGHAI SANYOU MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

HEARTMATE 3 Left Ventricular Assist System (LVAS)

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

SANYOU Spinal Rod System (Thoracolumbar) 6

Manufacturer:

SHANGHAI SANYOU MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

SANYOU Spinal Rod System (Cervical) Instrument

Manufacturer:

SHANGHAI SANYOU MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 14, 2025

INGEVITY™+ Lead

Manufacturer:

BOSTON SCIENTIFIC PUERTO RICO LLC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 13, 2025

INGEVITY™ MRI Lead

Manufacturer:

BOSTON SCIENTIFIC PUERTO RICO LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 13, 2025

RELIANCE 4-FRONT™ Active Fixation

Manufacturer:

BOSTON SCIENTIFIC PUERTO RICO LLC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 4, 2025

STIMULAN KIT

Manufacturer:

BIOCOMPOSITES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 2, 2025

STIMULAN RAPID CURE

Manufacturer:

BIOCOMPOSITES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2024

STRYKER Connected OR Hub System

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

SANYOU Spinal Rod System (Thoracolumbar) 2

Manufacturer:

SHANGHAI SANYOU MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

SANYOU Spinal Rod System (Thoracolumbar)

Manufacturer:

SHANGHAI SANYOU MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

STRYKER Connected OR Cart

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 21, 2024

STRYKER Hysteroscope Instrument

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

HAEMONETICS Cell Saver 5/5+ Bowl Kit

Manufacturer:

HAEMONETICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

MIM System, Image Processing, Radiological

Manufacturer:

MIM SOFTWARE INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

HAEMONETICS Sequestration Kit

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

HAEMONETICS Theraupetic Plasma Exchange (TPE) Set

Manufacturer:

HAEMONETICS MALAYSIA SDN BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

MosaiQ Enhancement Reagent 1

Manufacturer:

ALBA BIOSCIENCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2024

MosaiQ Enhancement Reagent 2

Manufacturer:

ALBA BIOSCIENCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2024

MosaiQ 125

Manufacturer:

STRATEC SE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

VERRATA Plus Pressure Guide Wire

Manufacturer:

PHILIPS DE COSTA RICA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

MOSAIQ AiPlex CTD

Manufacturer:

ALIVEDX SWITZERLAND Ltd

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

SPY Portable Handled Imaging (SPY-PHI) System

Manufacturer:

NOVADAQ TECHNOLOGIES ULC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2024

WEGO OXYGENATOR

Manufacturer:

SHANDONG WEGO TUOWEI MEDICAL DEVICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2024

MosaiQ Wash Buffer 1

Manufacturer:

ALBA BIOSCIENCE LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 28, 2024

STIMULAN Bullet & Mat Introducer

Manufacturer:

BIOCOMPOSITES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2024

ESSENTIO™ MRI EL DR Pacemaker

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 19, 2024

ESSENTIO MRI SR Pacemaker

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 19, 2024

ESSENTIO™ MRI DR Pacemaker

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 19, 2024

HAEMONETICS ACP 215 Automated Cell Processor and Accessories

Manufacturer:

SANMINA-SCI SYSTEMS (MALAYSIA) SDN BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2024

STRYKER FLOSTEADY Arthroscopy Pump

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2024

STRYKER CrossFlow® Integrated Arthroscopy Pump

Manufacturer:

STRYKER ENDOSCOPY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2024

STRYKER 1788 4K Camera System with Advanced Imaging Modality

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

CENTINEL PRODISC-L

Manufacturer:

CENTINEL SPINE, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

HAEMONETICS MCS + System and Accessories

Manufacturer:

SANMINA - SCI SYSTEMS (M) SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

STRYKER Pneumoclear System

Manufacturer:

W. O. M WORLD OF MEDICINE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2024

Precision Ideal Eyes 4K Arthroscope

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

STRYKER Pneumo Sure XL High Flow Insufflator

Manufacturer:

STRYKER ENDOSCOPY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

HAEMONETICS Cell Saver Elite Fast Pack

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

TEDAN Phantom MIS & Lateral

Manufacturer:

TEDAN SURGICAL INNOVATIONS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2024

TEDAN Phantom Open Lumbar

Manufacturer:

TEDAN SURGICAL INNOVATIONS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 24, 2024

TEDAN Phantom Cervical

Manufacturer:

TEDAN SURGICAL INNOVATIONS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 24, 2024

HAEMONETICS Cell Saver Elite Processing Kits

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2024

HAEMONETICS MCS+ System and Accessories

Manufacturer:

SANMINA- SCI SYSTEMS (MALAYSIA) SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 12, 2024

STRYKER Laparoscopy Set

Manufacturer:

STRYKER ENDOSCOPY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2024

STRYKER Arthroscopy Manual Instrument Set

Manufacturer:

STRYKER ENDOSCOPY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2024

HAEMONETICS TAE SET (00944-00)

Manufacturer:

HAEMONETICS MALAYSIA SDN BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

HAEMONETICS Aspiration/Anticoagulation Set

Manufacturer:

KAWASUNI LABORATORIES (THAILAND) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

HAEMONETICS Cell Saver Collection Reservior, Hard-Shell

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

AQUADEX SmartFlow Console

Manufacturer:

NUWELLIS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

HAEMONETICS Peripheral Blood Stem Cell (PBSC) Set

Manufacturer:

HAEMONETICS MALAYSIA SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

HAEMONETICS PLT & PLS Set Double Dose

Manufacturer:

HAEMONETICS MALAYSIA SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

HAEMONETICS RC High Efficiency Leucocyte Removal Filter With Attached Set For Blood Transfusion

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

STRYKER Arthroscopes Instrument

Manufacturer:

STRYKER ENDOSCOPY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

REFINITY Rotational IVUS Imaging Catheter

Manufacturer:

PHILIPS DE COSTA RICA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2024

BMS Sterile Tube Welder

Manufacturer:

WUHAN BMS MEDICALTECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 26, 2024

EAGLE EYE Platinum Digital IVUS Catheter

Manufacturer:

PHILIPS DE COSTA RICA, S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2024

OMNIWIRE Pressure Guide Wire

Manufacturer:

PHILIPS DE COSTA RICA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

VISIONS PV.035 Digital IVUS Catheter

Manufacturer:

PHILIPS DE COSTA RICA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

HAEMONETICS RC High Efficiency Leucocyte Removal Filter With Attached Set For Blood Transfusion

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 22, 2024

SAGINOVA HDR Afterloading System

Manufacturer:

BEBIG MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2024

VISIONS PV.018 Digital IVUS Catheter

Manufacturer:

PHILIPS DE COSTA RICA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2024

SAGINOVA HDR Afterloading System Instruments

Manufacturer:

BEBIG MEDICAL GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2024

SJM MASTERS Series Aortic Valved Graft with Hemashield Graft Technology

Manufacturer:

ST. JUDE MEDICAL, PUERTO RICO, LLC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 7, 2024

THORATEC CENTRI MAG Extracorporeal Blood Pumping System

Manufacturer:

THORATEC SWITZERLAND GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

BELMONT Hyperthermia Pump

Manufacturer:

BELMONT MEDICAL TECHNOLOGIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

STRYKER L10 LED Light Source with AIM Technology

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

ABIONIC IVD CAPSULE Control PSP

Manufacturer:

ABIONIC Ltd

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

STRYKER VisionPro 26'' LED Display

Manufacturer:

D&T INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

SJM REGENT Mechanical Heart Valve

Manufacturer:

ST. JUDE MEDICAL, PUERTO RICO, LLC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 9, 2024

JAFRON Future F20 Hemoadsorption Equipment

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

JAFRON DNA 230 DNA Immunoadsorbent Colomn

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

STRYKER 1588 AIM System

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2024

NEXSYS PCS™

Manufacturer:

SANMINA-SCI SYSTEMS (MALAYSIA) SDN. BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 2, 2024

HeartMate Touch™ Communication System

Manufacturer:

THORATEC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

SJM Masters HP Series Valved Graft with Gelweave Valsalva Technology

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO., LLC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 24, 2024

JAFRON BS80 Disposable Plasma Bilirubin Perfusion Adsorption Colomn

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2024

JAFRON HA60 Disposable Hemoperfusion Cartridge

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

JAFRON HA 280 Disposable Hemoperfusion Cartridge

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

STRYKER 1688 4K Camera Control unit with Advance Imaging Modality

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

HAEMONETICS PL HIGH Efficiency Leucocyte Removal Filter with Attached SET for Platelet Transfusion

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING S DE RL DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 16, 2024

STRYKER SPY Laparoscopes

Manufacturer:

QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

JAFRON Dispossible Hemoperfusion Cartridge

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 20, 2024

TULSA - PRO System

Manufacturer:

PROFOUND MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 11, 2024

THORATEC HeartMate III™ Left Ventricular Assist System

Manufacturer:

THORATEC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 6, 2024

ABIONIC AbioSCOPE Control

Manufacturer:

ABIONIC SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

AHTO Irrigation Pump

Manufacturer:

STRYKER ENDOSCOPY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2024

SJM Rigid Saddle Ring

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2024

SJM™ Seguin Annuloplasty Ring for Mitral Valve Repair

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2024

I-STAT Kaolin ACT Cartridge

Manufacturer:

ABBOTT POINT OF CARE CANADA, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 20, 2024

SJM Tailor Annuloplasty Ring

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 19, 2024

EMBLEM MRI S-ICD System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 17, 2024

HEALAFLOW

Manufacturer:

BIO-STERIL SAS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

I-STAT ACT Control Level 1

Manufacturer:

CLINIQA CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2024

CROSSFIRE 2 System (0475100000)

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2024

JAFRON Hemoperfusion Machine

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2024

JAFRON Disposable Plasma Bilirubin Perfusion Adsorption Column

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2024

JAFRON Dispossible Hemoperfusion Cartridge

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2024

JAFRON Dispossible Hemoperfusion Cartridge

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2024

SONALLEVE MR-HIFU V2 INGENIA 1.5T

Manufacturer:

PROFOUND MEDICAL OY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 19, 2024

SONALLEVE MR-HIFU V2 ACHIEVA 1.5T

Manufacturer:

PROFOUND MEDICAL OY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 19, 2024

RENATRON II 100 Dialyzer Reprocessing System

Manufacturer:

MEDIVATORS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2024

RENATRON PA 100 Dialyzer Reprocessing System

Manufacturer:

MEDIVATORS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2024

NUWELLIS Dual Lumen Catheter and Insertion Kit

Manufacturer:

NUWELLIS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 16, 2024

NUWELLIS 6Fr Dual Lumen ELC, Venous Access Catheter with Stainless Steel Coil Reinforcement

Manufacturer:

NUWELLIS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 16, 2024

RENALIN 100 Cold Sterilant

Manufacturer:

MEDIVATORS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 16, 2024

HEMOFLOW 400XS Blood Mixer And Scale System With Related Accessories

Manufacturer:

APPLIED SCIENCE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2024

COMPORT TRIMO

Manufacturer:

RET, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 8, 2024

HemoFlow 400 Basic and Accessories

Manufacturer:

APPLIED SCIENCE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2024

MOMENTUM™ EL ICD DR

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 28, 2023

CENTINEL PRODISC-C VIVO

Manufacturer:

CENTINEL SPINE, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2023

CENTINEL STALIF C-TI

Manufacturer:

CENTINEL SPINE, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

i-STAT TriControls Control Level 3

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2023

i-STAT TriControls Control Level 2

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2023

i-STAT TriControls Control Level 1

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2023

i-STAT TriControls Calibration Verification Set Levels 1-5

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2023

I-STAT CK-MB Calibration Verification Set

Manufacturer:

CLINIQA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

i-STAT CK-MB Control Level 2

Manufacturer:

CLINIQA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

i-STAT CK-MB Control Level 1

Manufacturer:

CLINIQA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

I-STAT CK-MB Control Level 3

Manufacturer:

CLINIQA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

I-DROP Pur Gel

Manufacturer:

EXCELVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

SJM ™ Rigid Saddle Ring Sizer Set

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

I-DROP MGD

Manufacturer:

EXCELVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 9, 2023

Abionic IVD Capsule PSP

Manufacturer:

ABIONIC Ltd

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

Abionic IVD Capsule Ferritin

Manufacturer:

ABIONIC Ltd

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

Abionic IVD Capsule D-Dimer

Manufacturer:

ABIONIC Ltd

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

CHALICE VAD Tubing Pack

Manufacturer:

CHALICE MEDICAL LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

ABIONIC AbioSCOPE

Manufacturer:

ABIONIC Ltd

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

I-DROP PUR

Manufacturer:

EXCELVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

BLEPHEX Hand Piece

Manufacturer:

SHENZHEN RELISH TECHNOLOGY CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 18, 2023

I-STAT 1 Analyzer 300-G and Accessories

Manufacturer:

FLEXTRONIC MANUFACTURING (SINGAPORE) PTE, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2023

i-STAT Alinity System and Accessories

Manufacturer:

ABBOTT POINT OF CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2023

SJM Masters Series Mechanical Heart Valve Sets

Manufacturer:

ST. JUDE MEDICAL, PUERTO RICO, LLC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 7, 2023

PROTECTALON 2.0%

Manufacturer:

VSY BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY JOINT STOCK COMPANY

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 18, 2023

Protectalon 1.4%

Manufacturer:

VSY BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY JOINT STOCK COMPANY

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 18, 2023

I-STAT CK-MB Cartridge

Manufacturer:

ABBOTT POINT OF CARE INC CANADA LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

I-STAT Chem8+ Cartridge

Manufacturer:

ABBOTT POINT OF CARE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2023

LENTIS Mplus Toric Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 25, 2023

JAFRON Dispossible Hemoperfusion Cartridge

Manufacturer:

JAFRON BIOMEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 21, 2023

PROTECTALON 3.0%

Manufacturer:

VSY BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY JOINT STOCK COMPANY

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 25, 2023

PAUL Glaucoma Implant

Manufacturer:

SUNNINGDALE TECH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2023

LENTIS Tplus X Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 26, 2023

LENTIS Tplus Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 26, 2023

LENTIS Mplus X Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 23, 2023

LENTIS Comfort Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 23, 2023

LENTIS Quantum Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 22, 2023

LENTIS Mplus X Toric Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 22, 2023

LENTIS Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 22, 2023

LENTIS Mplus Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 19, 2023

LENTIS Comfort Toric Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 19, 2023

FEMTIS Comfort Toric Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 13, 2023

FEMTIS Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 13, 2023

FEMTIS Mplus Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 13, 2023

FEMTIS Comfort Intraocular Lens

Manufacturer:

TELEON SURGICAL B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 27, 2023

RADIXACT Treatment Delivery System

Manufacturer:

ACCURAY INCORPORATED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2023

WEGO Blood Bag CPDA-1

Manufacturer:

SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 28, 2023

WEGO Blood Bag CPDA-1

Manufacturer:

SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 27, 2023

SCANDIDOS DELTA4 PHANTOM+

Manufacturer:

SCANDIDOS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 27, 2023

Protectalon 1.8%

Manufacturer:

VSY BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY JOINT STOCK COMPANY

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

TEG 5000 Level II Control

Manufacturer:

HAEMONETICS CORPORATION (CLINTON)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

TEG Hemostasis System 0.2M CaCI2

Manufacturer:

HAEMONETICS CORPORATION, CLINTON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2022

TEG® 5000 Level I Control

Manufacturer:

HAEMONETICS CORPORATION, CLINTON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

TEG 5000 Kaolin

Manufacturer:

HAEMONETICS CORPORATION, CLINTON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

TEG 5000 Disposable Cups and Pins Heparinase

Manufacturer:

HAEMONETICS CORPORATION, CLINTON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

DYNAGEN™ EL ICD DR

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 12, 2022

MOMENTUM™ EL ICD VR

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 8, 2022

DYNAGEN™ EL ICD VR

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 23, 2022

CHARISMA™ EL ICD DR

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 23, 2022

CHARISMA™ EL ICD VR

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 23, 2022

HAEMONETICS RBC De-Glycerol/Cell Wash Set

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2022

AUTOSTOP In-Process Filter System For Buffy Coat Platelets

Manufacturer:

HAEMONETICS MANUFACTURING INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2022

HAEMONETICS BMB PLS Bowls

Manufacturer:

HAEMONETICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 29, 2022

HAEMONETICS Cell Saver Elite+ Autotransfusion System

Manufacturer:

SANMINA-SCI SYSTEMS (MALAYSIA) SDN. BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2022

HAEMONETICS® RBC Glycerolization Set

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2022

CYBERKNIFE Treatment Delivery System

Manufacturer:

ACCURAY INCORPORATED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 11, 2022

TEG 5000 Disposable Cups and Pins Heparinase

Manufacturer:

HAEMONETICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 10, 2022

HAEMONETICS TEG 5000 Hemostasis Analyzer System and Accessories

Manufacturer:

SPARTRONICS STRONGSVILLE INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2021

HAEMONETICS RBC Glycerolization Set

Manufacturer:

HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2021

HAEMONETICS PLS Harness Set w/Drip

Manufacturer:

PT. JMS BATAM

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2021

RAD SOURCE X-Ray Blood Irradiator

Manufacturer:

RAD SOURCE TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2021

TEG 5000 Kaolin

Manufacturer:

HAEMONETICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2021

TEG Hemostasis System 0.2M CaCI2

Manufacturer:

HAEMONETICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2021

TEG 5000 Level II Control

Manufacturer:

HAEMONETICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2021

TEG 5000 Level I Control

Manufacturer:

HAEMONETICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2021

MEICEN Thermoplastic Fixation Mask For Radiotherapy

Manufacturer:

GUANGZHOU RENFU MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2021

HAEMONETICS PLS Bag

Manufacturer:

HAEMONETICS MALAYSIA SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2021

MEICEN Baseplate

Manufacturer:

GUANGZHOU RENFU MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 9, 2021

RIVACOR 7 HF-T QP

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 1, 2021

HAEMONECTICS Post-Process Filter System for Platelets

Manufacturer:

HAEMONECTICS MANUFACTURING INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2021

HAEMONETICS Cell Saver Elite Autotransfusion System

Manufacturer:

SANMINA CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2021

MEICEN Thermoplastic Fixation Mask for Radiotherapy

Manufacturer:

GUANGZHOU RENFU MEDICAL EQUIPMENT.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 18, 2021

AUTOSTOP In-Process Filter System For Buffy Coat Platelets

Manufacturer:

HAEMONETICS MANUFACTURING INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2021

HAEMONETICS RC Leucocyte Filter for Blood

Manufacturer:

HAEMONETICS MANUFACTURING INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2021

HAEMONETICS RC Leucocyte Filter For Blood

Manufacturer:

HAEMONETICS MANUFACTURING INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2021

HAEMONETICS CPD-50 Anticoagulant Solution

Manufacturer:

TERUMO BCT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

HAEMONETICS SAG-M Red Blood Cell Preservative Solution

Manufacturer:

TERUMO BCT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

INFOMED FLUIDS ACD-A Anticoagulant Solution

Manufacturer:

INFOMED FLUIDS S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2020

INFOMED FLUIDS Sodium Citrate 4% Anticoagulant Solution

Manufacturer:

INFOMED FLUIDS S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

PHILIPS VOLCANO Core Precision Guided Therapy System

Manufacturer:

VOLCANO CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

HAEMONETICS ELX Platelet Storage Bag

Manufacturer:

HAEMONETICS MANUFACTURING INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2020

PIONEER Plus Catheter

Manufacturer:

VIANT AS & O HOLDINGS, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2020

SJM™ Pericardial Patch with EnCap ™ Technology

Manufacturer:

GLYCAR S.A.(PTY) LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 7, 2020

Connected OR Hub System and Accessories

Manufacturer:

NOVATECH S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2020

HAEMONETICS PL Leucocyte Filter for Platelets

Manufacturer:

HAEMONETICS MANUFACTURING INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2020

MEICEN Thermoplastic Fixation Mask for Radiotherapy

Manufacturer:

GUANGZHOU RENFU MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2020

HAEMONETICS Post Process Filter System

Manufacturer:

HAEMONETICS MANUFACTURING INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 27, 2020

KIWI OMNICUP Vacuum Delivery System

Manufacturer:

CLINICAL INNOVATIONS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2020

KIWI OmniCup Vaccum Delivery System with Traction Force

Manufacturer:

CLINICAL INNOVATIONS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2020

KIWI Omni-C Cup Vacuum Delivery System

Manufacturer:

CLINICAL INNOVATIONS, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2020

RIVACOR 7 VR-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 24, 2020

RIVACOR 5 HF-T QP

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 20, 2020

RIVACOR 5 VR-T DX

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 20, 2020

RIVACOR 5 HF-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 20, 2020

RIVACOR 3 HF-T QP

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 17, 2020

RIVACOR 7 VR-T DX

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 16, 2020

RIVACOR 7 HF-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 13, 2020

RIVACOR 3 HF-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 13, 2020

RIVACOR 5 DR-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 13, 2020

RIVACOR 7 DR-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 13, 2020

RIVACOR 3 DR-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 12, 2020

RIVACOR 5 VR-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 9, 2020

TRIFECTA Valve with Glide Technology

Manufacturer:

ST. JUDE MEDICAL COSTA RICA LTDA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 8, 2020

RIVACOR 3 VR-T

Manufacturer:

BIOTRONIC SE & CO. KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 7, 2020

INTUITIVE SURGICAL DA VINCI SI- E Surgical System

Manufacturer:

INTUITIVE SURGICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2020

TRINITY

Manufacturer:

KOELIS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2020

TRIFECTA Valve with Glide Technology

Manufacturer:

ST. JUDE MEDICAL BRAZIL LTDA.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 1, 2020

SELECTRA Slitter

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2020

LIFECODES LSA™ Class I Kit

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2020

HAEMONETICS 2-RBC Set W/Filter

Manufacturer:

HAEMONETICS MALAYSIA SDN BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2019

HAEMONETICS Post Process Filter System

Manufacturer:

HAEMONETICS MANUFACTURING INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2019

HAEMONETICS PLT & PLS Set with Filter

Manufacturer:

HAEMONETICS MALAYSIA SDN BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2019

STRYKER 1488 HD Camera System & Control Unit

Manufacturer:

STRYKER ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2019

Thoratec HeartMate II Left Ventricular Assist System

Manufacturer:

THORATEC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 3, 2019

SELECTRA

Manufacturer:

BIOTRONIK SE & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 19, 2019

Intica 7 VR-T

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 5, 2019

LIFECODES HLA-DQA1/B1 SSO TYPING KIT For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2019

LIFECODES HLA-DRB1 eRES SSO TYPING KIT For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2019

Plexa ProMRI SD

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 14, 2019

LIFECODES HLA NULL ALLELE SSO TYPING KIT For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2019

LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2019

LIFECODES HLA-C eRES SSO Typing Kit For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2019

LIFECODES HLA-DRB1 SSO Typing Kit For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2019

LIFECODES HLA-B eRES SSO Typing Kit For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2019

LIFECODES HLA-A eRES SSO TYPING KIT For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2019

LIFECODES HLA-DPA1/B1 SSO Typing Kit For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2019

LIFECODES HLA-B SSO Typing Kit For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2019

LIFECODES HLA-A SSO Typing Kit For Use With Luminex

Manufacturer:

IMMUCOR GTI DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2019

REVOLUTION 45 MHz Rotational Imaging Catheter

Manufacturer:

VOLCANO CORPORATION BY VOLCARICA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2019

Sentus ProMRI OTW QP S-XX/49

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 13, 2019

Plexa ProMRI DF-1 S DX

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

Plexa Pro MRI DF-1 SD

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

Sentus ProMRI OTW QP L

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

INTICA 7 DR-T

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

Sentus ProMRI OTW BP L

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

Sentus ProMRI OTW BP S

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

Sentus ProMRI OTW QP S

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

INTICA 7 VR-T DX

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

INTICA 5 VR-T

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

Sentus ProMRI OTW QP L-XX/49

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

Plexa ProMRI S

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

Plexa ProMRI DF-1 S

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

INTICA 5 DR-T

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 19, 2019

INTICA 5 HF-T QP

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 28, 2019

INTICA 7 HF-T QP

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 21, 2019

INTICA 7 HF-T

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 21, 2019

INTICA 5 HF-T

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 21, 2019

INTICA 5 VR-T DX

Manufacturer:

BIOTRONIK SE & CO., KG

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2018

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

Last updated: December 2025