BRK ™ Transseptal Needle - Indonesia BPOM Medical Device Registration
BRK ™ Transseptal Needle is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501027282. The device is manufactured by ABBOTT MEDICAL COSTA RICA LTDA from Costa Rica, and is classified as Risk Class Kelas Resiko : B. 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 : 2
Manufacturer
ABBOTT MEDICAL COSTA RICA LTDACountry of Origin
Costa Rica
Authorized Representative
PT. NUGRA KARSERAAR Address
Rukan Graha Mas Pemuda, Jalan Pemuda Blok AA/ 10
Registration Date
Sep 18, 2023
Expiry Date
Jun 27, 2028
Product Type
Diagnostic Cardiology Equipment
Catheter stylet.
Non Electromedic Sterile
TACTIFLEX™ Sensor Enabled™ Ablation Catheter
ADVISOR ™ VL Circular Mapping Catheter, Sensor Enabled ™
FlexAbility ™ Sensor Enabled ™ Ablation Catheter
FLEXABILITY™ Ablation Catheter
INQUIRY ™ Steerable Diagnostic Catheter
ADVISOR™ HD Grid Mapping Catheter, Sensor Enabled ™
SUPREME™ Electrophysiology Catheter
ADVISOR ™ FL Circular Mapping Catheter, Sensor Enabled™
EnSite X EP System Surface Electrode Kit
TACTICATH ™ Contact Force Ablation Catheter, Sensor Enabled ™
TACTIFLEX™ Sensor Enabled™ Ablation Catheter
ABBOTT MEDICAL COSTA RICA LTDA
TACTIFLEX ™ Sensor Enabled ™ Ablation Catheter
ABBOTT MEDICAL
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.

