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BALANCIUM™ PTCA Guide Wire - Indonesia BPOM Medical Device Registration

BALANCIUM™ PTCA Guide Wire is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505810792. The device is manufactured by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAIN REVASS MEDIKA.

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 : C
BALANCIUM™ PTCA Guide Wire
Analysis ID: AKL 20505810792

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MAIN REVASS MEDIKA

AR Address

Jl. Dewi Sartika No. 4B RT 004/007 Kel. Cililitan Kec. Kramat jati

Registration Date

Oct 10, 2023

Expiry Date

Jun 07, 2028

Product Type

Therapeutic Cardiology Equipment

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Non Electromedic Sterile

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