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OPTIMA NC Non Compliant PTCA Balloon Catheter - Indonesia BPOM Medical Device Registration

OPTIMA NC Non Compliant PTCA Balloon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501420248. The device is manufactured by TRANSLUMINA THERAPEUTICS LLP from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is Dharma Saputra Medica.

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
OPTIMA NC Non Compliant PTCA Balloon Catheter
Analysis ID: AKL 20501420248

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

India

Authorized Representative

Dharma Saputra Medica

AR Address

JL. SUMATERA NO. 31 A RT.02/RW.04

Registration Date

Apr 30, 2024

Expiry Date

Dec 31, 2028

Product Type

Diagnostic Cardiology Equipment

Percutaneous catheter.

Non Electromedic Sterile

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