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Direct-X Rx PTCA Pre-Dilatation Balloon Catheter - Indonesia BPOM Medical Device Registration

Direct-X Rx PTCA Pre-Dilatation Balloon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501420034. The device is manufactured by PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is HARMONY PRIMA 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
Direct-X Rx PTCA Pre-Dilatation Balloon Catheter
Analysis ID: AKL 20501420034

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

India

Authorized Representative

HARMONY PRIMA MEDIKA

AR Address

Jl. Tanjung Selor No. 1A, Cideng, Gambir, Jakarta Pusat, 10150

Registration Date

Jan 18, 2024

Expiry Date

Nov 28, 2028

Product Type

Diagnostic Cardiology Equipment

Percutaneous catheter.

Non Electromedic Sterile

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