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QDOT MICRO Bi-Directional Navigation Catheter - Indonesia BPOM Medical Device Registration

QDOT MICRO Bi-Directional Navigation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30501320704. 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 AND JOHNSON INDONESIA TWO.

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
QDOT MICRO Bi-Directional Navigation Catheter
Analysis ID: AKL 30501320704

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Mexico

Authorized Representative

PT. JOHNSON AND JOHNSON INDONESIA TWO

AR Address

K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A, Kuningan, Setiabudi, Jakarta Selatan, Desa/Kelurahan Kuningan Timur, Kec. Setiabudi, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12950

Registration Date

Apr 27, 2023

Expiry Date

Dec 08, 2027

Product Type

Diagnostic Cardiology Equipment

Cardiac ablation percutaneous catheter

Non Electromedic Sterile

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