SPOTCHEM EL and Accessories - Indonesia BPOM Medical Device Registration
SPOTCHEM EL and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102220183. The device is manufactured by ARKRAY INDUSTRY, INC from Philippines, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ARKRAY.
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
ARKRAY INDUSTRY, INCCountry of Origin
Philippines
Authorized Representative
PT. ARKRAYAR Address
Gedung Mega Plaza Lt. 12, Jl. HR. Rasuna Said Kav. C - 3
Registration Date
Aug 15, 2022
Expiry Date
Jan 11, 2027
Product Type
Clinical Laboratory Equipment
Electrolyte analyzer
Invitro Diagnostics
SPOTCHEM™ II Liver-1 (LDH, GPT/ALT, GOT/AST, Albumin, Total Protein, Total Bilirubin)
ARKRAY FACTORY, INC.
SPOTCHEM II STAT-1 (LDH, CPK, GPT/ALT, GOT/AST, Blood Urea Nitrogen, 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 HDL-Cholesterol (Direct Method)
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.