AIKANG D-Dimer In Vitro Diagnostic Kit (D-Dimer) - Indonesia BPOM Medical Device Registration

AIKANG D-Dimer In Vitro Diagnostic Kit (D-Dimer) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207220115. The device is manufactured by AIKANG DIAGNOSTICS CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BIOGEN SCIENTIFIC.

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BPOM Registered

Risk Class Kelas Resiko : C

AIKANG D-Dimer In Vitro Diagnostic Kit (D-Dimer)

Analysis ID: AKL 20207220115

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

AIKANG DIAGNOSTICS CO., LTD.

Country of Origin

China

Authorized Representative

PT. BIOGEN SCIENTIFIC

AR Address

Rukan Tanjung Mas Raya Jl.Raya Lenteng Agung Blok B1 No.21

Registration Date

Aug 16, 2022

Expiry Date

Jul 01, 2024

Product Type

Haematology Package and Kit

Fibrinogen/fibrin degradation products assay.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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