POCKETCHEM UA PU-4010 and Accessories - Indonesia BPOM Medical Device Registration
POCKETCHEM UA PU-4010 and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102911263. The device is manufactured by ARKRAY FACTORY INC. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ARKRAY.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ARKRAY FACTORY INC.Country of Origin
Japan
Authorized Representative
PT. ARKRAYAR Address
Gedung Mega Plaza Lt. 12 Jl. HR. Rasuna Said Kav. C - 3
Registration Date
Mar 28, 2019
Expiry Date
May 31, 2024
Product Type
Clinical Laboratory Equipment
Automated urinalysis system.
Invitro Diagnostics
SPOTCHEM™ II HDL-Cholesterol (Direct Method)
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SPOTCHEM II STAT-1 (LDH, CPK, GPT/ALT, GOT/AST, Blood Urea Nitrogen, Total Bilirubin)
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SPOTCHEM™ II Liver-1 (LDH, GPT/ALT, GOT/AST, Albumin, Total Protein, Total Bilirubin)
ARKRAY FACTORY, INC.
SPOTCHEM II Panel-1 (GPT/ALT, GOT/AST, Blood Urea Nitrogen, Glucose, Total Cholesterol, Total Bilirubin)
ARKRAY FACTORY, INC.
SPOTCHEM ™ II CPK
ARKRAY FACTORY, INC.
SPOTCHEM™ II Amylase
ARKRAY FACTORY, INC.
SPOTCHEM II ALP
ARKRAY FACTORY, INC.
SPOTCHEM™ II Inorganic Phosphorus
ARKRAY FACTORY, INC.
COBIO S50 Fully Automated Urine Sediment Analyzer
COBIO SMART HEALTHCARE TECHNOLOGY CO., LTD.
SPOTCHEM™ II Uric Acid
ARKRAY FACTORY, INC.