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ELUTAX SV-PTA-OTW - Indonesia BPOM Medical Device Registration

ELUTAX SV-PTA-OTW is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505717285. The device is manufactured by AACHEN RESONANCE GMBH. from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. DIPA PHARMALAB INTERSAINS.

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
ELUTAX SV-PTA-OTW
Analysis ID: AKL 30505717285

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Germany

Authorized Representative

PT. DIPA PHARMALAB INTERSAINS

AR Address

Jalan Raya Kebayoran Lama No. 28

Registration Date

Feb 25, 2021

Expiry Date

Dec 17, 2025

Product Type

Therapeutic Cardiology Equipment

Drug Eluting Balloon

Non Electromedic Sterile

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