SAFIRE ™ Bi-directional Ablation Catheter - Indonesia BPOM Medical Device Registration
SAFIRE ™ Bi-directional Ablation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30504120636. The device is manufactured by ABBOTT MEDICAL from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. NUGRA KARSERA.
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
ABBOTT MEDICALCountry of Origin
United States
Authorized Representative
PT. NUGRA KARSERAAR Address
Rukan Graha Mas Pemuda, Jalan Pemuda Blok AA/ 10
Registration Date
Aug 12, 2024
Expiry Date
Dec 31, 2025
Product Type
Surgical Cardiology Equipment
Cardiac ablation percutaneous catheter
Non Electromedic Sterile
TACTICATH™ Contact Force Ablation Catheter, Sensor Enabled™
ISOFLEX Lead
TACTIFLEX ™ Sensor Enabled ™ Ablation Catheter
QUICKFLEX™ µ Left Heart Lead
QUARTET™ Left Heart Lead
HEARTMATE 3 Left Ventricular Assist System (LVAS)
TactiSys ™ Quartz Equipment
ELLIPSE™ VR Implantable Cardioverter Defibrillator
TENDRIL STS Pacing Leads
ELLIPSE™ DR Implantable Cardioverter Defibrillator
TACTIFLEX ™ Sensor Enabled ™ Ablation Catheter
ABBOTT MEDICAL
TACTIFLEX™ Sensor Enabled™ Ablation Catheter
ABBOTT MEDICAL COSTA RICA LTDA
AXS Universal Aspiration Tubing
MEDELA AG
TactiSys ™ Quartz Equipment
ABBOTT MEDICAL
NUGRA Hydrophilic Guide Wire
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
ADVISOR ™ VL Circular Mapping Catheter, Sensor Enabled ™
ABBOTT MEDICAL COSTA RICA LTDA
Z-MED ™ Percutaneous Transluminal Valvulopasty Catheter
NUMED INC.
NUGRA Manifold
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
NUGRA High Pressure Extension Tubing
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
NUGRA Angiographic Catheter
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.