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QUADROX-i Oxygenator - Indonesia BPOM Medical Device Registration

QUADROX-i Oxygenator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504718449. The device is manufactured by MAQUET CARDIOPULMONARY LTD. from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is INDOSOPHA SAKTI.

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
QUADROX-i Oxygenator
Analysis ID: AKL 20504718449

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

INDOSOPHA SAKTI

AR Address

JL. MAMPANG PRAPATAN RAYA NO.1

Registration Date

Dec 24, 2024

Expiry Date

Dec 31, 2025

Product Type

Surgical Cardiology Equipment

Cardiopulmonary bypass oxygenator.

Non Electromedic Sterile

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