API 20 E - Indonesia BPOM Medical Device Registration
API 20 E is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10302903660. The device is manufactured by BIOMERIEUX SA from France, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
BIOMERIEUX SACountry of Origin
France
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
Nov 07, 2022
Expiry Date
Dec 31, 2026
Product Type
Microbiology Equipment
Selective culture medium.
Invitro Diagnostics
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VIDAS Anti-HEV IgM (HEVM)
VIDAS Anti-HEV IgG (HEVG)
VIDAS Anti-DENGUE IgM (DENM)
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LIVES DENGUE NS1 Ag (DEAG)
VIDAS EBV VCA/EA IgG (VCAG)
VIDAS EBV VCA IgM (VCAM)
VIDAS EBV EBNA IgG (EBNA)
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