Elva A1cChek Pro Analyzer - Indonesia BPOM Medical Device Registration
Elva A1cChek Pro Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207420103. The device is manufactured by WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO. from China, 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
WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO.Country of Origin
China
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
Jul 29, 2024
Expiry Date
Dec 31, 2026
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
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