ASSURITY MRI Pulse Generator - Indonesia BPOM Medical Device Registration
ASSURITY MRI Pulse Generator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503814420. The device is manufactured by ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD. from Malaysia, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 3
Manufacturer
ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.Country of Origin
Malaysia
Authorized Representative
PT. TAWADA HEALTHCAREAR Address
Rukan Permata Senayan Blok A18-19 Lantai 5 Jl. Tentara Pelajar No. 5
Registration Date
Sep 20, 2024
Expiry Date
Apr 08, 2029
Product Type
Prosthetic Cardiology Equipment
Implantable pacemaker pulse generator.
Non Radiation Electromedics
DURATAโข Defibrillator Lead
DURATA Defibrillation Lead
ASSURITY MRI Pulse Generator
ELLIPSE DR
ENDURITY Core Pulse Generator
ELLIPSE VR Implantable Cardioverter Defibrillator
ENDURITY Core
ENDURITY Pulse Generator
ALLURE RF Cardiac Resynchronization Therapy Device Pulse Generator
QUADRA ALLURE MP Cardiac Resynchronization Therapy Device, Pulse Generator
QUANTUM 2 (RF 12000)
SMITH & NEPHEW INC, ENDOSCOPY DIVISION
QUARTETโข Left Heart Lead
ABBOTT MEDICAL
ISOFLEX Lead
ABBOTT MEDICAL
SMITH & NEPHEW Fast Fix Instruments
ARTHROCARE CORPORATION
TWINFIX Ti Suture Anchors
ARTHROCARE CORPORATION
QUICKFLEXโข ยต Left Heart Lead
ABBOTT MEDICAL
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.
SMITH & NEPHEW Genesis II Instrument
STRAITS ORTHOPAEDICS (MFG) SDN., BHD.
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.

