AltaChem Pro Auto Chemistry Analyzer and Accessories - Indonesia BPOM Medical Device Registration
AltaChem Pro Auto Chemistry Analyzer and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102320431. The device is manufactured by GENRUI BIOTECH INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
GENRUI BIOTECH INC.Country of Origin
China
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Mar 01, 2023
Expiry Date
Feb 27, 2026
Product Type
Clinical Laboratory Equipment
Clinical chemistry analyzer
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