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ONYX TruStar Zotarolimus-Eluting Coronary Stent System - Indonesia BPOM Medical Device Registration

ONYX TruStar Zotarolimus-Eluting Coronary Stent System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505320268. The device is manufactured by METRONIC IRELAND from Ireland, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. MEDTRONIC INDONESIA.

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
ONYX TruStar Zotarolimus-Eluting Coronary Stent System
Analysis ID: AKL 30505320268

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

METRONIC IRELAND

Country of Origin

Ireland

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama

Registration Date

Sep 07, 2023

Expiry Date

Feb 07, 2028

Product Type

Therapeutic Cardiology Equipment

Drug Eluting Balloon

Non Electromedic Sterile

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