ECOTEST Fluorescence Immunoassay Analyzer - Indonesia BPOM Medical Device Registration
ECOTEST Fluorescence Immunoassay Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304121601. The device is manufactured by ASSURE TECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. VIPRO MEDITECH PRATAMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ASSURE TECH (HANGZHOU) CO., LTD.Country of Origin
China
Authorized Representative
PT. VIPRO MEDITECH PRATAMAAR Address
Puri Metropolitan Blok G1/21, Petir
Registration Date
Mar 23, 2021
Expiry Date
Jun 28, 2025
Product Type
Immunology Laboratory Equipment and Reagents
Immunofluorometer equipment
Invitro Diagnostics
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