GEM Hematocrit Evaluator 2 - Indonesia BPOM Medical Device Registration
GEM Hematocrit Evaluator 2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323773. The device is manufactured by INSTRUMENTATION LABORATORY COMPANY 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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Risk Classification
Product Class
Kelas : 2
Manufacturer
INSTRUMENTATION LABORATORY COMPANYCountry of Origin
United States
Authorized Representative
PT. ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
Jun 28, 2024
Expiry Date
Dec 31, 2027
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
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