VIDAS D-Dimer Exclusion II Dex2 - Indonesia BPOM Medical Device Registration
VIDAS D-Dimer Exclusion II Dex2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207113216. The device is manufactured by BIOMERIEUX SA. from France, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ENSEVAL MEDIKA PRIMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BIOMERIEUX SA.Country of Origin
France
Authorized Representative
ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
Aug 19, 2024
Expiry Date
Dec 31, 2028
Product Type
Haematology Package and Kit
Fibrinogen/fibrin degradation products assay.
Invitro Diagnostics
BIOMERIEUX Color Gram 2
ID Color Catalase ( ID - ASE )
VIDAS CMV IgM CMVM
PREVI Color Gram Fuchsin Solution-RA4
LIVES Testosteron II (TES2)
VIDAS Anti-TG (ATG)
VIDAS Anti-HCV
VIDAS Anti-TPO (ATPO)
VIDAS Cortisol S (CORS)
B.R.A.H.M.S PCT LIVES
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
BIOMERIEUX SA.
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.