GEM CVP 3 Hematocrit - Indonesia BPOM Medical Device Registration
GEM CVP 3 Hematocrit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101717103. 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 ENSEVAL MEDIKA PRIMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
INSTRUMENTATION LABORATORY COMPANY.Country of Origin
United States
Authorized Representative
ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
May 07, 2021
Expiry Date
Oct 28, 2024
Product Type
Clinical Chemistry Test System
Calibrator (cair)
Invitro Diagnostics
HEMOSIL Apixaban Calibrators
HEMOSIL Apixaban Controls
HEMOSIL Rivaroxaban Calibrators
HEMOSIL Rivaroxaban Controls
HEMOSIL Protein S Activity
HEMOSIL La Positive Control
HEMOSIL La Negative Control
HEMOSIL Rinse Solution
HEMOSIL Protein C
HEMOSIL Factor IX Deficient Plasma
ELVASENSE Mini Safety Lancet
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
VIDAS® IFNg QC PANEL (IFNg QC)
BIOMERIEUX S.A. (CHEMIN DE L'ORME)., FRANCE
ID Color Catalase ( ID - ASE )
BIOMERIEUX SA.
BIOMERIEUX Oxidase Reagent
REMEL
VITEK 2 AST-N425
BIOMERIEUX INC.
B.R.A.H.M.S PCT LIVES
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ELVASENSE Blood Glucose Test Strip
TAIDOC TECHNOLOGY CORPORATION
BIOMERIEUX Serum Free
BIOMERIEUX S.A.
Eppendorf Centrifuge 5425R
EPPENDORF SE, GERMANY
VIDAS HBs Ag Ultra Confirmation
BIOMERIEUX SA.