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AmiCORE Apheresis System - Indonesia BPOM Medical Device Registration

AmiCORE Apheresis System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209126185. The device is manufactured by FRESENIUS HEMOCARE GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FRESENIUS KABI 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 : B
AmiCORE Apheresis System
Analysis ID: AKL 20209126185

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

PT. FRESENIUS KABI INDONESIA

AR Address

Menara Bidakara 1 Lt 19, Jl. Jend Gatot Subroto Kav 71-73

Registration Date

Dec 13, 2024

Expiry Date

Mar 24, 2026

Product Type

Products used in the manufacture of blood preparations and preparations of origin and blood

Automated blood cell separator.

Invitro Diagnostics

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