HELIOSTAR Balloon Ablation Catheter - Indonesia BPOM Medical Device Registration
HELIOSTAR Balloon Ablation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30501220050. The device is manufactured by BIOSENSE WEBSTER, INC. from Mexico, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is JOHNSON & JOHNSON NEW ZEALAND.
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
BIOSENSE WEBSTER, INC.Country of Origin
Mexico
Authorized Representative
JOHNSON & JOHNSON NEW ZEALANDAR Address
K-Link Tower Lt. 12, Jln. Jend. Gatot Subroto Kav. 59 A
Registration Date
Feb 14, 2022
Expiry Date
Mar 18, 2026
Product Type
Diagnostic Cardiology Equipment
Cardiac ablation percutaneous catheter
Non Electromedic Sterile
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