OPTIMUS Test HBsAg Serum One Step Diagnostic Rapid Test (Strip) - Indonesia BPOM Medical Device Registration

OPTIMUS Test HBsAg Serum One Step Diagnostic Rapid Test (Strip) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305320699. The device is manufactured by ATLAS LINK TECHNOLOGY CO.,LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. NARWASTU MEDIKA.

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BPOM Registered

Risk Class Kelas Resiko : D

OPTIMUS Test HBsAg Serum One Step Diagnostic Rapid Test (Strip)

Analysis ID: AKL 30305320699

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

ATLAS LINK TECHNOLOGY CO.,LTD.

Country of Origin

China

Authorized Representative

PT. NARWASTU MEDIKA

AR Address

Jl. Daan Mogot km.20 No.411A Kelurahan Kebon Besar

Registration Date

Feb 09, 2023

Expiry Date

Feb 06, 2026

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Kelas Resiko : C

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Kelas Resiko : C

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