Authorized representative profile
PT. TRANSMEDIC INDONESIA
Registered address
- Address
- 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
Total Products
102
Manufacturers
3
Product Classes
4
Risk Classes
Risk classification breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
10
3.7% of total
Kelas Resiko : B
93
34.7% of total
Kelas Resiko : C
88
32.8% of total
Kelas Resiko : D
77
28.7% of total
Manufacturer portfolio
Products organized by manufacturer
BIOTRONIK SE & CO., KG
22 ProductsGermany
TELEON SURGICAL B.V.
14 ProductsNetherlands
LENTIS Mplus Toric Intraocular LensJul 25, 2023
Kelas Resiko : D
LENTIS Tplus X Intraocular LensMay 26, 2023
Kelas Resiko : D
LENTIS Tplus Intraocular LensMay 26, 2023
Kelas Resiko : D
LENTIS Mplus X Intraocular LensMay 23, 2023
Kelas Resiko : D
LENTIS Comfort Intraocular LensMay 23, 2023
Kelas Resiko : D
View all 14 products from this manufacturer →BIOTRONIC SE & CO. KG
14 ProductsGermany
IMMUCOR GTI DIAGNOSTICS, INC.
12 ProductsUnited States
LIFECODES LSA™ Class I KitJan 17, 2020
Kelas Resiko : B
LIFECODES HLA-DQA1/B1 SSO TYPING KIT For Use With LuminexJun 18, 2019
Kelas Resiko : B
LIFECODES HLA-DRB1 eRES SSO TYPING KIT For Use With LuminexJun 14, 2019
Kelas Resiko : B
LIFECODES HLA NULL ALLELE SSO TYPING KIT For Use With LuminexMay 10, 2019
Kelas Resiko : B
LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit For Use With LuminexMay 8, 2019
Kelas Resiko : B
View all 12 products from this manufacturer →11 Products
JAFRON Future F20 Hemoadsorption EquipmentMay 7, 2024
Kelas Resiko : C
JAFRON DNA 230 DNA Immunoadsorbent ColomnMay 7, 2024
Kelas Resiko : C
JAFRON BS80 Disposable Plasma Bilirubin Perfusion Adsorption ColomnApr 23, 2024
Kelas Resiko : C
JAFRON HA60 Disposable Hemoperfusion CartridgeApr 18, 2024
Kelas Resiko : C
JAFRON HA 280 Disposable Hemoperfusion CartridgeApr 18, 2024
Kelas Resiko : C
View all 11 products from this manufacturer →STRYKER ENDOSCOPY
10 ProductsUnited States
STRYKER Connected OR Hub SystemDec 2, 2024
Kelas Resiko : B
STRYKER Connected OR CartNov 21, 2024
Kelas Resiko : A
STRYKER Hysteroscope InstrumentOct 28, 2024
Kelas Resiko : B
STRYKER 1788 4K Camera System with Advanced Imaging ModalityAug 4, 2024
Kelas Resiko : B
Precision Ideal Eyes 4K ArthroscopeJul 29, 2024
Kelas Resiko : B
View all 10 products from this manufacturer →BOSTON SCIENTIFIC LIMITED
10 ProductsIreland
ESSENTIO™ MRI EL DR PacemakerAug 19, 2024
Kelas Resiko : D
ESSENTIO MRI SR PacemakerAug 19, 2024
Kelas Resiko : D
ESSENTIO™ MRI DR PacemakerAug 19, 2024
Kelas Resiko : D
EMBLEM MRI S-ICD SystemFeb 17, 2024
Kelas Resiko : D
MOMENTUM™ EL ICD DRDec 28, 2023
Kelas Resiko : D
View all 10 products from this manufacturer →STRYKER ENDOSCOPY.
6 ProductsUnited States
STRYKER CrossFlow® Integrated Arthroscopy PumpAug 7, 2024
Kelas Resiko : B
STRYKER Pneumo Sure XL High Flow InsufflatorJul 29, 2024
Kelas Resiko : B
STRYKER Laparoscopy SetJul 12, 2024
Kelas Resiko : B
STRYKER Arthroscopy Manual Instrument SetJul 12, 2024
Kelas Resiko : B
STRYKER Arthroscopes InstrumentJun 28, 2024
Kelas Resiko : B
View all 6 products from this manufacturer →HAEMONETICS MANUFACTURING INC.
6 ProductsUnited States
AUTOSTOP In-Process Filter System For Buffy Coat PlateletsFeb 25, 2021
Kelas Resiko : B
HAEMONETICS RC Leucocyte Filter for BloodFeb 11, 2021
Kelas Resiko : B
HAEMONETICS RC Leucocyte Filter For BloodFeb 11, 2021
Kelas Resiko : B
HAEMONETICS PL Leucocyte Filter for PlateletsSep 2, 2020
Kelas Resiko : C
HAEMONETICS Post Process Filter SystemAug 27, 2020
Kelas Resiko : C
View all 6 products from this manufacturer →5 Products
SANYOU Spinal Rod System (Cervical) ImplantFeb 11, 2025
Kelas Resiko : C
SANYOU Spinal Rod System (Thoracolumbar) 6Jan 30, 2025
Kelas Resiko : C
SANYOU Spinal Rod System (Cervical) InstrumentJan 14, 2025
Kelas Resiko : A
SANYOU Spinal Rod System (Thoracolumbar) 2Dec 2, 2024
Kelas Resiko : C
SANYOU Spinal Rod System (Thoracolumbar)Dec 2, 2024
Kelas Resiko : C
ABBOTT MEDICAL
5 ProductsUnited States
HEARTMATE 3 Left Ventricular Assist System (LVAS)Feb 6, 2025
Kelas Resiko : D
SJM Rigid Saddle RingFeb 22, 2024
Kelas Resiko : C
SJM™ Seguin Annuloplasty Ring for Mitral Valve RepairFeb 22, 2024
Kelas Resiko : C
SJM Tailor Annuloplasty RingFeb 19, 2024
Kelas Resiko : C
SJM ™ Rigid Saddle Ring Sizer SetNov 13, 2023
Kelas Resiko : B
HAEMONETICS CORPORATION.
5 ProductsUnited States
5 Products
HAEMONETICS RC High Efficiency Leucocyte Removal Filter With Attached Set For Blood TransfusionJul 2, 2024
Kelas Resiko : C
HAEMONETICS RC High Efficiency Leucocyte Removal Filter With Attached Set For Blood TransfusionJun 22, 2024
Kelas Resiko : C
HAEMONETICS RBC De-Glycerol/Cell Wash SetOct 31, 2022
Kelas Resiko : C
HAEMONETICS® RBC Glycerolization SetFeb 2, 2022
Kelas Resiko : B
HAEMONETICS RBC Glycerolization SetDec 10, 2021
Kelas Resiko : B
ABIONIC Ltd
5 ProductsSwitzerland
4 Products
BIONOSTICS, INC.
4 ProductsUnited States
CLINIQA CORPORATION
4 ProductsUnited States
HAEMONETICS CORPORATION, CLINTON
4 ProductsUnited States
BIOCOMPOSITES LIMITED
3 ProductsUnited Kingdom
HAEMONETICS MALAYSIA SDN BHD.
3 ProductsMalaysia
ALBA BIOSCIENCE LTD.
3 ProductsUnited Kingdom
PHILIPS DE COSTA RICA S.R.L
3 ProductsCosta Rica
CENTINEL SPINE, LLC
3 ProductsUnited States
TEDAN SURGICAL INNOVATIONS, INC.
3 ProductsUnited States
NUWELLIS, INC.
3 ProductsUnited States
ST. JUDE MEDICAL, PUERTO RICO, LLC.
3 ProductsUnited States
THORATEC CORPORATION
3 ProductsUnited States
MEDIVATORS INC.
3 ProductsUnited States
3 Products
BOSTON SCIENTIFIC PUERTO RICO LLC.
2 ProductsPuerto Rico USA
HAEMONETICS MALAYSIA SDN., BHD.
2 ProductsMalaysia
PHILIPS DE COSTA RICA S.R.L.
2 ProductsCosta Rica
2 Products
APPLIED SCIENCE, INC.
2 ProductsUnited States
EXCELVISION
2 ProductsFrance
ACCURAY INCORPORATED
2 ProductsUnited States
2 Products
HAEMONETICS MANUFACTURING INC
2 ProductsUnited States
HAEMONETICS CORPORATION
2 ProductsUnited States
TERUMO BCT LTD.
2 ProductsUnited Kingdom
INFOMED FLUIDS S.R.L.
2 ProductsRomania
CLINICAL INNOVATIONS, LLC
2 ProductsUnited States
BOSTON SCIENTIFIC PUERTO RICO LLC
1 ProductsPuerto Rico USA
MIM SOFTWARE INC.
1 ProductsUnited States
STRATEC SE
1 ProductsGermany
ALIVEDX SWITZERLAND Ltd
1 ProductsSwitzerland
NOVADAQ TECHNOLOGIES ULC
1 ProductsCanada
1 Products
1 Products
1 Products
1 Products
1 Products
1 Products
1 Products
PHILIPS DE COSTA RICA, S.R.L
1 ProductsCosta Rica
BEBIG MEDICAL GMBH
1 ProductsGermany
THORATEC SWITZERLAND GMBH.
1 ProductsSwitzerland
BELMONT MEDICAL TECHNOLOGIES.
1 ProductsUnited States
ST. JUDE MEDICAL PUERTO RICO., LLC.
1 ProductsUnited States
1 Products
1 Products
ABIONIC SA.
1 ProductsSwitzerland
1 Products
BIO-STERIL SAS
1 ProductsFrance
CLINIQA CORPORATION.
1 ProductsUnited States
RET, INC
1 ProductsKorea
CHALICE MEDICAL LTD
1 ProductsUnited Kingdom
EXCELVISION.
1 ProductsFrance
1 Products
ABBOTT POINT OF CARE, INC.
1 ProductsUnited States
1 Products
SUNNINGDALE TECH LTD.
1 ProductsSingapore
SCANDIDOS.
1 ProductsSweden
HAEMONETICS CORPORATION (CLINTON)
1 ProductsUnited States
SPARTRONICS STRONGSVILLE INC.
1 ProductsUnited States
PT. JMS BATAM
1 ProductsIndonesian
RAD SOURCE TECHNOLOGIES, INC.
1 ProductsUnited States
HAEMONECTICS MANUFACTURING INC.
1 ProductsUnited States
SANMINA CORPORATION.
1 ProductsMalaysia
1 Products
VOLCANO CORPORATION.
1 ProductsUnited States
VIANT AS & O HOLDINGS, LLC.
1 ProductsUnited States
GLYCAR S.A.(PTY) LTD
1 ProductsSouth Africa
CLINICAL INNOVATIONS, LLC.
1 ProductsUnited States
ST. JUDE MEDICAL COSTA RICA LTDA
1 ProductsCosta Rica
INTUITIVE SURGICAL INC.
1 ProductsUnited States
KOELIS
1 ProductsFrance
1 Products
HAEMONETICS MALAYSIA SDN BHD
1 ProductsMalaysia
BIOTRONIK SE & CO., KG.
1 ProductsGermany
All represented products (268)
Complete portfolio registered with BPOM
SANYOU Spinal Rod System (Cervical) ImplantFeb 11, 2025
Manufacturer: SHANGHAI SANYOU MEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HEARTMATE 3 Left Ventricular Assist System (LVAS)Feb 6, 2025
Manufacturer: ABBOTT MEDICAL
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SANYOU Spinal Rod System (Thoracolumbar) 6Jan 30, 2025
Manufacturer: SHANGHAI SANYOU MEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SANYOU Spinal Rod System (Cervical) InstrumentJan 14, 2025
Manufacturer: SHANGHAI SANYOU MEDICAL CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
INGEVITY™+ LeadJan 13, 2025
Manufacturer: BOSTON SCIENTIFIC PUERTO RICO LLC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INGEVITY™ MRI LeadJan 13, 2025
Manufacturer: BOSTON SCIENTIFIC PUERTO RICO LLC
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RELIANCE 4-FRONT™ Active FixationJan 4, 2025
Manufacturer: BOSTON SCIENTIFIC PUERTO RICO LLC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
STIMULAN KITJan 2, 2025
Manufacturer: BIOCOMPOSITES LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STIMULAN RAPID CUREDec 13, 2024
Manufacturer: BIOCOMPOSITES LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRYKER Connected OR Hub SystemDec 2, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SANYOU Spinal Rod System (Thoracolumbar) 2Dec 2, 2024
Manufacturer: SHANGHAI SANYOU MEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SANYOU Spinal Rod System (Thoracolumbar)Dec 2, 2024
Manufacturer: SHANGHAI SANYOU MEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRYKER Connected OR CartNov 21, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 1
Risk Class: Kelas Resiko : A
STRYKER Hysteroscope InstrumentOct 28, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS Cell Saver 5/5+ Bowl KitOct 7, 2024
Manufacturer: HAEMONETICS CORPORATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MIM System, Image Processing, RadiologicalOct 1, 2024
Manufacturer: MIM SOFTWARE INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS Sequestration KitOct 1, 2024
Manufacturer: HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS Theraupetic Plasma Exchange (TPE) SetOct 1, 2024
Manufacturer: HAEMONETICS MALAYSIA SDN BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MosaiQ Enhancement Reagent 1Sep 24, 2024
Manufacturer: ALBA BIOSCIENCE LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MosaiQ Enhancement Reagent 2Sep 24, 2024
Manufacturer: ALBA BIOSCIENCE LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MosaiQ 125Sep 17, 2024
Manufacturer: STRATEC SE
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VERRATA Plus Pressure Guide WireSep 17, 2024
Manufacturer: PHILIPS DE COSTA RICA S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MOSAIQ AiPlex CTDSep 17, 2024
Manufacturer: ALIVEDX SWITZERLAND Ltd
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SPY Portable Handled Imaging (SPY-PHI) SystemSep 10, 2024
Manufacturer: NOVADAQ TECHNOLOGIES ULC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
WEGO OXYGENATORAug 30, 2024
Manufacturer: SHANDONG WEGO TUOWEI MEDICAL DEVICE CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MosaiQ Wash Buffer 1Aug 28, 2024
Manufacturer: ALBA BIOSCIENCE LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
STIMULAN Bullet & Mat IntroducerAug 21, 2024
Manufacturer: BIOCOMPOSITES LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ESSENTIO™ MRI EL DR PacemakerAug 19, 2024
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ESSENTIO MRI SR PacemakerAug 19, 2024
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ESSENTIO™ MRI DR PacemakerAug 19, 2024
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
HAEMONETICS ACP 215 Automated Cell Processor and AccessoriesAug 12, 2024
Manufacturer: SANMINA-SCI SYSTEMS (MALAYSIA) SDN BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
STRYKER FLOSTEADY Arthroscopy PumpAug 7, 2024
Manufacturer: W.O.M. WORLD OF MEDICINE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
STRYKER CrossFlow® Integrated Arthroscopy PumpAug 7, 2024
Manufacturer: STRYKER ENDOSCOPY.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
STRYKER 1788 4K Camera System with Advanced Imaging ModalityAug 4, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CENTINEL PRODISC-LAug 4, 2024
Manufacturer: CENTINEL SPINE, LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS MCS + System and AccessoriesAug 4, 2024
Manufacturer: SANMINA - SCI SYSTEMS (M) SDN., BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
STRYKER Pneumoclear SystemJul 31, 2024
Manufacturer: W. O. M WORLD OF MEDICINE GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Precision Ideal Eyes 4K ArthroscopeJul 29, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
STRYKER Pneumo Sure XL High Flow InsufflatorJul 29, 2024
Manufacturer: STRYKER ENDOSCOPY.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS Cell Saver Elite Fast PackJul 29, 2024
Manufacturer: HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TEDAN Phantom MIS & LateralJul 29, 2024
Manufacturer: TEDAN SURGICAL INNOVATIONS, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
TEDAN Phantom Open LumbarJul 24, 2024
Manufacturer: TEDAN SURGICAL INNOVATIONS, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
TEDAN Phantom CervicalJul 24, 2024
Manufacturer: TEDAN SURGICAL INNOVATIONS, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
HAEMONETICS Cell Saver Elite Processing KitsJul 24, 2024
Manufacturer: HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS MCS+ System and AccessoriesJul 12, 2024
Manufacturer: SANMINA- SCI SYSTEMS (MALAYSIA) SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRYKER Laparoscopy SetJul 12, 2024
Manufacturer: STRYKER ENDOSCOPY.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
STRYKER Arthroscopy Manual Instrument SetJul 12, 2024
Manufacturer: STRYKER ENDOSCOPY.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS TAE SET (00944-00)Jul 11, 2024
Manufacturer: HAEMONETICS MALAYSIA SDN BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS Aspiration/Anticoagulation SetJul 5, 2024
Manufacturer: KAWASUNI LABORATORIES (THAILAND) CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS Cell Saver Collection Reservior, Hard-ShellJul 3, 2024
Manufacturer: HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AQUADEX SmartFlow ConsoleJul 2, 2024
Manufacturer: NUWELLIS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS Peripheral Blood Stem Cell (PBSC) SetJul 2, 2024
Manufacturer: HAEMONETICS MALAYSIA SDN., BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS PLT & PLS Set Double DoseJul 2, 2024
Manufacturer: HAEMONETICS MALAYSIA SDN., BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS RC High Efficiency Leucocyte Removal Filter With Attached Set For Blood TransfusionJul 2, 2024
Manufacturer: HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRYKER Arthroscopes InstrumentJun 28, 2024
Manufacturer: STRYKER ENDOSCOPY.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
REFINITY Rotational IVUS Imaging CatheterJun 26, 2024
Manufacturer: PHILIPS DE COSTA RICA S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BMS Sterile Tube WelderJun 26, 2024
Manufacturer: WUHAN BMS MEDICALTECH CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
EAGLE EYE Platinum Digital IVUS CatheterJun 26, 2024
Manufacturer: PHILIPS DE COSTA RICA, S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OMNIWIRE Pressure Guide WireJun 24, 2024
Manufacturer: PHILIPS DE COSTA RICA S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VISIONS PV.035 Digital IVUS CatheterJun 24, 2024
Manufacturer: PHILIPS DE COSTA RICA S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS RC High Efficiency Leucocyte Removal Filter With Attached Set For Blood TransfusionJun 22, 2024
Manufacturer: HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SAGINOVA HDR Afterloading SystemJun 13, 2024
Manufacturer: BEBIG MEDICAL GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VISIONS PV.018 Digital IVUS CatheterJun 11, 2024
Manufacturer: PHILIPS DE COSTA RICA S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SAGINOVA HDR Afterloading System InstrumentsJun 10, 2024
Manufacturer: BEBIG MEDICAL GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SJM MASTERS Series Aortic Valved Graft with Hemashield Graft TechnologyJun 7, 2024
Manufacturer: ST. JUDE MEDICAL, PUERTO RICO, LLC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
THORATEC CENTRI MAG Extracorporeal Blood Pumping SystemJun 6, 2024
Manufacturer: THORATEC SWITZERLAND GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BELMONT Hyperthermia PumpJun 3, 2024
Manufacturer: BELMONT MEDICAL TECHNOLOGIES.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
STRYKER L10 LED Light Source with AIM TechnologyMay 27, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABIONIC IVD CAPSULE Control PSPMay 21, 2024
Manufacturer: ABIONIC Ltd
Class: Kelas : 2
Risk Class: Kelas Resiko : B
STRYKER VisionPro 26'' LED DisplayMay 14, 2024
Manufacturer: D&T INC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SJM REGENT Mechanical Heart ValveMay 9, 2024
Manufacturer: ST. JUDE MEDICAL, PUERTO RICO, LLC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
JAFRON Future F20 Hemoadsorption EquipmentMay 7, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
JAFRON DNA 230 DNA Immunoadsorbent ColomnMay 7, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRYKER 1588 AIM SystemMay 2, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
NEXSYS PCS™May 2, 2024
Manufacturer: SANMINA-SCI SYSTEMS (MALAYSIA) SDN. BHD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HeartMate Touch™ Communication SystemApr 30, 2024
Manufacturer: THORATEC CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SJM Masters HP Series Valved Graft with Gelweave Valsalva TechnologyApr 24, 2024
Manufacturer: ST. JUDE MEDICAL PUERTO RICO., LLC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
JAFRON BS80 Disposable Plasma Bilirubin Perfusion Adsorption ColomnApr 23, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
JAFRON HA60 Disposable Hemoperfusion CartridgeApr 18, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
JAFRON HA 280 Disposable Hemoperfusion CartridgeApr 18, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRYKER 1688 4K Camera Control unit with Advance Imaging ModalityApr 16, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS PL HIGH Efficiency Leucocyte Removal Filter with Attached SET for Platelet TransfusionApr 16, 2024
Manufacturer: HAEMONETICS MEXICO MANUFACTURING S DE RL DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRYKER SPY LaparoscopesMar 22, 2024
Manufacturer: QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
JAFRON Dispossible Hemoperfusion CartridgeMar 20, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TULSA - PRO SystemMar 11, 2024
Manufacturer: PROFOUND MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
THORATEC HeartMate III™ Left Ventricular Assist SystemMar 6, 2024
Manufacturer: THORATEC CORPORATION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ABIONIC AbioSCOPE ControlFeb 28, 2024
Manufacturer: ABIONIC SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
AHTO Irrigation PumpFeb 22, 2024
Manufacturer: STRYKER ENDOSCOPY.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SJM Rigid Saddle RingFeb 22, 2024
Manufacturer: ABBOTT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SJM™ Seguin Annuloplasty Ring for Mitral Valve RepairFeb 22, 2024
Manufacturer: ABBOTT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : C
I-STAT Kaolin ACT CartridgeFeb 20, 2024
Manufacturer: ABBOTT POINT OF CARE CANADA, LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SJM Tailor Annuloplasty RingFeb 19, 2024
Manufacturer: ABBOTT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EMBLEM MRI S-ICD SystemFeb 17, 2024
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
HEALAFLOWFeb 6, 2024
Manufacturer: BIO-STERIL SAS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
I-STAT ACT Control Level 1Feb 5, 2024
Manufacturer: CLINIQA CORPORATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CROSSFIRE 2 System (0475100000)Feb 2, 2024
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : C
JAFRON Hemoperfusion MachineFeb 1, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
JAFRON Disposable Plasma Bilirubin Perfusion Adsorption ColumnFeb 1, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
JAFRON Dispossible Hemoperfusion CartridgeJan 31, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
JAFRON Dispossible Hemoperfusion CartridgeJan 31, 2024
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SONALLEVE MR-HIFU V2 INGENIA 1.5TJan 19, 2024
Manufacturer: PROFOUND MEDICAL OY.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SONALLEVE MR-HIFU V2 ACHIEVA 1.5TJan 19, 2024
Manufacturer: PROFOUND MEDICAL OY
Class: Kelas : 2
Risk Class: Kelas Resiko : C
RENATRON II 100 Dialyzer Reprocessing SystemJan 17, 2024
Manufacturer: MEDIVATORS INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
RENATRON PA 100 Dialyzer Reprocessing SystemJan 17, 2024
Manufacturer: MEDIVATORS INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NUWELLIS Dual Lumen Catheter and Insertion KitJan 16, 2024
Manufacturer: NUWELLIS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NUWELLIS 6Fr Dual Lumen ELC, Venous Access Catheter with Stainless Steel Coil ReinforcementJan 16, 2024
Manufacturer: NUWELLIS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
RENALIN 100 Cold SterilantJan 16, 2024
Manufacturer: MEDIVATORS INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HEMOFLOW 400XS Blood Mixer And Scale System With Related AccessoriesJan 9, 2024
Manufacturer: APPLIED SCIENCE, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COMPORT TRIMOJan 8, 2024
Manufacturer: RET, INC
Class: Kelas : 1
Risk Class: Kelas Resiko : A
HemoFlow 400 Basic and AccessoriesJan 8, 2024
Manufacturer: APPLIED SCIENCE, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MOMENTUM™ EL ICD DRDec 28, 2023
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CENTINEL PRODISC-C VIVODec 21, 2023
Manufacturer: CENTINEL SPINE, LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CENTINEL STALIF C-TIDec 14, 2023
Manufacturer: CENTINEL SPINE, LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
i-STAT TriControls Control Level 3Dec 7, 2023
Manufacturer: BIONOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
i-STAT TriControls Control Level 2Dec 7, 2023
Manufacturer: BIONOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
i-STAT TriControls Control Level 1Dec 7, 2023
Manufacturer: BIONOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
i-STAT TriControls Calibration Verification Set Levels 1-5Dec 7, 2023
Manufacturer: BIONOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
I-STAT CK-MB Calibration Verification SetNov 23, 2023
Manufacturer: CLINIQA CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
i-STAT CK-MB Control Level 2Nov 23, 2023
Manufacturer: CLINIQA CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
i-STAT CK-MB Control Level 1Nov 23, 2023
Manufacturer: CLINIQA CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
I-STAT CK-MB Control Level 3Nov 23, 2023
Manufacturer: CLINIQA CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
I-DROP Pur GelNov 14, 2023
Manufacturer: EXCELVISION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SJM ™ Rigid Saddle Ring Sizer SetNov 13, 2023
Manufacturer: ABBOTT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
I-DROP MGDNov 9, 2023
Manufacturer: EXCELVISION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Abionic IVD Capsule PSPNov 8, 2023
Manufacturer: ABIONIC Ltd
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Abionic IVD Capsule FerritinNov 8, 2023
Manufacturer: ABIONIC Ltd
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Abionic IVD Capsule D-DimerNov 8, 2023
Manufacturer: ABIONIC Ltd
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CHALICE VAD Tubing PackNov 3, 2023
Manufacturer: CHALICE MEDICAL LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABIONIC AbioSCOPEOct 19, 2023
Manufacturer: ABIONIC Ltd
Class: Kelas : 2
Risk Class: Kelas Resiko : C
I-DROP PUROct 19, 2023
Manufacturer: EXCELVISION.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BLEPHEX Hand PieceSep 18, 2023
Manufacturer: SHENZHEN RELISH TECHNOLOGY CO.,LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
I-STAT 1 Analyzer 300-G and AccessoriesSep 12, 2023
Manufacturer: FLEXTRONIC MANUFACTURING (SINGAPORE) PTE, LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
i-STAT Alinity System and AccessoriesSep 12, 2023
Manufacturer: ABBOTT POINT OF CARE, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SJM Masters Series Mechanical Heart Valve SetsSep 7, 2023
Manufacturer: ST. JUDE MEDICAL, PUERTO RICO, LLC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PROTECTALON 2.0%Aug 18, 2023
Manufacturer: VSY BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY JOINT STOCK COMPANY
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Protectalon 1.4%Aug 18, 2023
Manufacturer: VSY BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY JOINT STOCK COMPANY
Class: Kelas : 3
Risk Class: Kelas Resiko : D
I-STAT CK-MB CartridgeAug 14, 2023
Manufacturer: ABBOTT POINT OF CARE INC CANADA LIMITED.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
I-STAT Chem8+ CartridgeAug 3, 2023
Manufacturer: ABBOTT POINT OF CARE LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LENTIS Mplus Toric Intraocular LensJul 25, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
JAFRON Dispossible Hemoperfusion CartridgeJul 21, 2023
Manufacturer: JAFRON BIOMEDICAL CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PROTECTALON 3.0%Jun 25, 2023
Manufacturer: VSY BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY JOINT STOCK COMPANY
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PAUL Glaucoma ImplantMay 29, 2023
Manufacturer: SUNNINGDALE TECH LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LENTIS Tplus X Intraocular LensMay 26, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LENTIS Tplus Intraocular LensMay 26, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LENTIS Mplus X Intraocular LensMay 23, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LENTIS Comfort Intraocular LensMay 23, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LENTIS Quantum Intraocular LensMay 22, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LENTIS Mplus X Toric Intraocular LensMay 22, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LENTIS Intraocular LensMay 22, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LENTIS Mplus Intraocular LensMay 19, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LENTIS Comfort Toric Intraocular LensMay 19, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
FEMTIS Comfort Toric Intraocular LensMay 13, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
FEMTIS Intraocular LensMay 13, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
FEMTIS Mplus Intraocular LensMay 13, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
FEMTIS Comfort Intraocular LensApr 27, 2023
Manufacturer: TELEON SURGICAL B.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RADIXACT Treatment Delivery SystemApr 19, 2023
Manufacturer: ACCURAY INCORPORATED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
WEGO Blood Bag CPDA-1Mar 28, 2023
Manufacturer: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
WEGO Blood Bag CPDA-1Mar 27, 2023
Manufacturer: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SCANDIDOS DELTA4 PHANTOM+Feb 27, 2023
Manufacturer: SCANDIDOS.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Protectalon 1.8%Feb 22, 2023
Manufacturer: VSY BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY JOINT STOCK COMPANY
Class: Kelas : 3
Risk Class: Kelas Resiko : D
TEG 5000 Level II ControlJan 25, 2023
Manufacturer: HAEMONETICS CORPORATION (CLINTON)
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TEG Hemostasis System 0.2M CaCI2Dec 29, 2022
Manufacturer: HAEMONETICS CORPORATION, CLINTON
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TEG® 5000 Level I ControlDec 27, 2022
Manufacturer: HAEMONETICS CORPORATION, CLINTON
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TEG 5000 KaolinDec 26, 2022
Manufacturer: HAEMONETICS CORPORATION, CLINTON
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TEG 5000 Disposable Cups and Pins HeparinaseDec 19, 2022
Manufacturer: HAEMONETICS CORPORATION, CLINTON
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DYNAGEN™ EL ICD DRDec 12, 2022
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MOMENTUM™ EL ICD VRDec 8, 2022
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
DYNAGEN™ EL ICD VRNov 23, 2022
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CHARISMA™ EL ICD DRNov 23, 2022
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CHARISMA™ EL ICD VRNov 23, 2022
Manufacturer: BOSTON SCIENTIFIC LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
HAEMONETICS RBC De-Glycerol/Cell Wash SetOct 31, 2022
Manufacturer: HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AUTOSTOP In-Process Filter System For Buffy Coat PlateletsAug 31, 2022
Manufacturer: HAEMONETICS MANUFACTURING INC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS BMB PLS BowlsAug 29, 2022
Manufacturer: HAEMONETICS CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS Cell Saver Elite+ Autotransfusion SystemFeb 10, 2022
Manufacturer: SANMINA-SCI SYSTEMS (MALAYSIA) SDN. BHD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS® RBC Glycerolization SetFeb 2, 2022
Manufacturer: HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CYBERKNIFE Treatment Delivery SystemJan 11, 2022
Manufacturer: ACCURAY INCORPORATED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TEG 5000 Disposable Cups and Pins HeparinaseJan 10, 2022
Manufacturer: HAEMONETICS CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS TEG 5000 Hemostasis Analyzer System and AccessoriesDec 10, 2021
Manufacturer: SPARTRONICS STRONGSVILLE INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS RBC Glycerolization SetDec 10, 2021
Manufacturer: HAEMONETICS MEXICO MANUFACTURING S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS PLS Harness Set w/DripDec 4, 2021
Manufacturer: PT. JMS BATAM
Class: Kelas : 2
Risk Class: Kelas Resiko : B
RAD SOURCE X-Ray Blood IrradiatorNov 11, 2021
Manufacturer: RAD SOURCE TECHNOLOGIES, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TEG 5000 KaolinSep 23, 2021
Manufacturer: HAEMONETICS CORPORATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TEG Hemostasis System 0.2M CaCI2Sep 23, 2021
Manufacturer: HAEMONETICS CORPORATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TEG 5000 Level II ControlSep 10, 2021
Manufacturer: HAEMONETICS CORPORATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TEG 5000 Level I ControlSep 7, 2021
Manufacturer: HAEMONETICS CORPORATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEICEN Thermoplastic Fixation Mask For RadiotherapyAug 25, 2021
Manufacturer: GUANGZHOU RENFU MEDICAL EQUIPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS PLS BagAug 24, 2021
Manufacturer: HAEMONETICS MALAYSIA SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEICEN BaseplateAug 9, 2021
Manufacturer: GUANGZHOU RENFU MEDICAL EQUIPMENT CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
RIVACOR 7 HF-T QPJul 1, 2021
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
HAEMONECTICS Post-Process Filter System for PlateletsJun 2, 2021
Manufacturer: HAEMONECTICS MANUFACTURING INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS Cell Saver Elite Autotransfusion SystemApr 22, 2021
Manufacturer: SANMINA CORPORATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEICEN Thermoplastic Fixation Mask for RadiotherapyMar 18, 2021
Manufacturer: GUANGZHOU RENFU MEDICAL EQUIPMENT.,LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AUTOSTOP In-Process Filter System For Buffy Coat PlateletsFeb 25, 2021
Manufacturer: HAEMONETICS MANUFACTURING INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS RC Leucocyte Filter for BloodFeb 11, 2021
Manufacturer: HAEMONETICS MANUFACTURING INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS RC Leucocyte Filter For BloodFeb 11, 2021
Manufacturer: HAEMONETICS MANUFACTURING INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS CPD-50 Anticoagulant SolutionJan 19, 2021
Manufacturer: TERUMO BCT LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS SAG-M Red Blood Cell Preservative SolutionJan 19, 2021
Manufacturer: TERUMO BCT LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INFOMED FLUIDS ACD-A Anticoagulant SolutionDec 18, 2020
Manufacturer: INFOMED FLUIDS S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INFOMED FLUIDS Sodium Citrate 4% Anticoagulant SolutionDec 15, 2020
Manufacturer: INFOMED FLUIDS S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHILIPS VOLCANO Core Precision Guided Therapy SystemDec 7, 2020
Manufacturer: VOLCANO CORPORATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS ELX Platelet Storage BagNov 29, 2020
Manufacturer: HAEMONETICS MANUFACTURING INC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PIONEER Plus CatheterNov 17, 2020
Manufacturer: VIANT AS & O HOLDINGS, LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SJM™ Pericardial Patch with EnCap ™ TechnologyOct 7, 2020
Manufacturer: GLYCAR S.A.(PTY) LTD
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Connected OR Hub System and AccessoriesSep 18, 2020
Manufacturer: NOVATECH S.A.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS PL Leucocyte Filter for PlateletsSep 2, 2020
Manufacturer: HAEMONETICS MANUFACTURING INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEICEN Thermoplastic Fixation Mask for RadiotherapyAug 31, 2020
Manufacturer: GUANGZHOU RENFU MEDICAL EQUIPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS Post Process Filter SystemAug 27, 2020
Manufacturer: HAEMONETICS MANUFACTURING INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KIWI OMNICUP Vacuum Delivery SystemAug 19, 2020
Manufacturer: CLINICAL INNOVATIONS, LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KIWI OmniCup Vaccum Delivery System with Traction ForceAug 19, 2020
Manufacturer: CLINICAL INNOVATIONS, LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KIWI Omni-C Cup Vacuum Delivery SystemAug 6, 2020
Manufacturer: CLINICAL INNOVATIONS, LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
RIVACOR 7 VR-TJul 24, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 5 HF-T QPJul 20, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 5 VR-T DXJul 20, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 5 HF-TJul 20, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 3 HF-T QPJul 17, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 7 VR-T DXJul 16, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 7 HF-TJul 13, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 3 HF-TJul 13, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 5 DR-TJul 13, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 7 DR-TJul 13, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 3 DR-TJul 12, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 5 VR-TJul 9, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
TRIFECTA Valve with Glide TechnologyJul 8, 2020
Manufacturer: ST. JUDE MEDICAL COSTA RICA LTDA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RIVACOR 3 VR-TJul 7, 2020
Manufacturer: BIOTRONIC SE & CO. KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTUITIVE SURGICAL DA VINCI SI- E Surgical SystemJun 23, 2020
Manufacturer: INTUITIVE SURGICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TRINITYJun 10, 2020
Manufacturer: KOELIS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TRIFECTA Valve with Glide TechnologyApr 1, 2020
Manufacturer: ST. JUDE MEDICAL BRAZIL LTDA.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SELECTRA SlitterMar 24, 2020
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LIFECODES LSA™ Class I KitJan 17, 2020
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HAEMONETICS 2-RBC Set W/FilterDec 30, 2019
Manufacturer: HAEMONETICS MALAYSIA SDN BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS Post Process Filter SystemDec 30, 2019
Manufacturer: HAEMONETICS MANUFACTURING INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAEMONETICS PLT & PLS Set with FilterDec 30, 2019
Manufacturer: HAEMONETICS MALAYSIA SDN BHD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRYKER 1488 HD Camera System & Control UnitNov 11, 2019
Manufacturer: STRYKER ENDOSCOPY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Thoratec HeartMate II Left Ventricular Assist SystemSep 3, 2019
Manufacturer: THORATEC CORPORATION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SELECTRAJul 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Intica 7 VR-TJul 5, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LIFECODES HLA-DQA1/B1 SSO TYPING KIT For Use With LuminexJun 18, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-DRB1 eRES SSO TYPING KIT For Use With LuminexJun 14, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Plexa ProMRI SDJun 14, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LIFECODES HLA NULL ALLELE SSO TYPING KIT For Use With LuminexMay 10, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit For Use With LuminexMay 8, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-C eRES SSO Typing Kit For Use With LuminexMay 8, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-DRB1 SSO Typing Kit For Use With LuminexMay 8, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-B eRES SSO Typing Kit For Use With LuminexMay 8, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-A eRES SSO TYPING KIT For Use With LuminexMay 7, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-DPA1/B1 SSO Typing Kit For Use With LuminexMay 7, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-B SSO Typing Kit For Use With LuminexMay 7, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIFECODES HLA-A SSO Typing Kit For Use With LuminexMay 6, 2019
Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
REVOLUTION 45 MHz Rotational Imaging CatheterApr 22, 2019
Manufacturer: VOLCANO CORPORATION BY VOLCARICA S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Sentus ProMRI OTW QP S-XX/49Apr 13, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Plexa ProMRI DF-1 S DXMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Plexa Pro MRI DF-1 SDMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Sentus ProMRI OTW QP LMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 7 DR-TMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Sentus ProMRI OTW BP LMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Sentus ProMRI OTW BP SMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Sentus ProMRI OTW QP SMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 7 VR-T DXMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 5 VR-TMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Sentus ProMRI OTW QP L-XX/49Mar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Plexa ProMRI SMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Plexa ProMRI DF-1 SMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 5 DR-TMar 19, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 5 HF-T QPFeb 28, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 7 HF-T QPFeb 21, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 7 HF-TFeb 21, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 5 HF-TFeb 21, 2019
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTICA 5 VR-T DXDec 31, 2018
Manufacturer: BIOTRONIK SE & CO., KG
Class: Kelas : 3
Risk Class: Kelas Resiko : D
About this profile
Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.
Last updated: July 2026