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CARDIOCEL Adapted Collagen Scaffold - Indonesia BPOM Medical Device Registration

CARDIOCEL Adapted Collagen Scaffold is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20503126107. The device is manufactured by ADMEDUS REGEN PTY LTD from Australia, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. GEM OF GRACE VIBRASA.

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BPOM Registered
Risk Class Kelas Resiko : C
CARDIOCEL Adapted Collagen Scaffold
Analysis ID: AKL 20503126107

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Australia

Authorized Representative

PT. GEM OF GRACE VIBRASA

AR Address

Perkantoran CBD Ciledug Jl. Hos Cokroaminoto No. 93 Ruko perkantoran CBD Ciledug Blok A3 No. 28

Registration Date

Jun 08, 2022

Expiry Date

Apr 21, 2026

Product Type

Prosthetic Cardiology Equipment

Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

Non Electromedic Sterile

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