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THERMOCOOL SMARTTOUCH™ Uni-Directional Navigation Catheter - Indonesia BPOM Medical Device Registration

THERMOCOOL SMARTTOUCH™ Uni-Directional Navigation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30501513176. 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 PT. 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.

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BPOM Registered
Risk Class Kelas Resiko : D
THERMOCOOL SMARTTOUCH™ Uni-Directional Navigation Catheter
Analysis ID: AKL 30501513176

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Mexico

Authorized Representative

PT. JOHNSON & JOHNSON NEW ZEALAND

AR Address

K-Link Tower Lt. 12, Jln. Jend. Gatot Subroto Kav. 59 A

Registration Date

May 20, 2022

Expiry Date

Mar 18, 2026

Product Type

Diagnostic Cardiology Equipment

Cardiac ablation percutaneous catheter

Non Electromedic Sterile

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