ETEST® Cefixime (IX) - Indonesia BPOM Medical Device Registration
ETEST® Cefixime (IX) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20301320107. The device is manufactured by BIOMERIEUX SA. (PORT MICHAUD) from France, 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
BIOMERIEUX SA. (PORT MICHAUD)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
Nov 08, 2023
Expiry Date
Dec 31, 2026
Product Type
Diagnostic Equipment
Antimicrobial susceptibility test disc.
Invitro Diagnostics
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ETEST Gentamicin (GM)
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ETEST Metronidazole (MZ)(0.016-256µg/mL)
ETEST Cefoxitin (FX)(0.016-256µg/mL)
ETEST Clindamycin (CM) (0.016-256 µg/mL)
ETEST Imipenem (IP) (0.002-32 µg/mL)
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VIDAS HBs Ag Ultra Confirmation
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