HEMOSIL Heparin Calibrators - Indonesia BPOM Medical Device Registration

HEMOSIL Heparin Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207719031. The device is manufactured by INSTRUMENTATION LABORATORY CO. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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BPOM Registered

Risk Class Kelas Resiko : B

HEMOSIL Heparin Calibrators

Analysis ID: AKL 20207719031

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

INSTRUMENTATION LABORATORY CO.

Country of Origin

United States

Authorized Representative

PT. ENSEVAL MEDIKA PRIMA

AR Address

JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG

Registration Date

Jul 29, 2024

Expiry Date

Dec 31, 2027

Product Type

Haematology Package and Kit

Heparin assay.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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