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SAPPHIRE 3 Coronary Dilatation Catheter - Indonesia BPOM Medical Device Registration

SAPPHIRE 3 Coronary Dilatation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505124843. The device is manufactured by ORBUSNEICH MEDICAL B.V. from Netherlands, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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
SAPPHIRE 3 Coronary Dilatation Catheter
Analysis ID: AKL 20505124843

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Netherlands

Authorized Representative

MAIN REVASS MEDIKA

AR Address

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

Registration Date

Aug 06, 2021

Expiry Date

Jun 16, 2026

Product Type

Therapeutic Cardiology Equipment

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Non Electromedic Sterile

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