AltaGel M Automated Blood Grouping Analyzer and Accessories - Indonesia BPOM Medical Device Registration

AltaGel M Automated Blood Grouping Analyzer and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209320698. The device is manufactured by AIKANG MEDTECH CO., LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.

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BPOM Registered

Risk Class Kelas Resiko : C

AltaGel M Automated Blood Grouping Analyzer and Accessories

Analysis ID: AKL 20209320698

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

AIKANG MEDTECH CO., LTD

Country of Origin

China

Authorized Representative

PT. FAITHFUL MEDICAL GRACE

AR Address

Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89

Registration Date

Nov 06, 2023

Expiry Date

Nov 03, 2026

Product Type

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

Automated blood grouping and antibody test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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