HEMOSIL dRVVT Screen - Indonesia BPOM Medical Device Registration
HEMOSIL dRVVT Screen is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208811489. The device is manufactured by INSTRUMENTATION LABORATORY CO. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
INSTRUMENTATION LABORATORY CO.Country of Origin
United States
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
Aug 19, 2024
Expiry Date
Dec 31, 2027
Product Type
Hematological Reagents
Russell viper venom reagent.
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