SPOTCHEM II Panel-1 (GPT/ALT, GOT/AST, Blood Urea Nitrogen, Glucose, Total Cholesterol, Total Bilirubin) - Indonesia BPOM Medical Device Registration
SPOTCHEM II Panel-1 (GPT/ALT, GOT/AST, Blood Urea Nitrogen, Glucose, Total Cholesterol, Total Bilirubin) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101511875. The device is manufactured by ARKRAY FACTORY, INC. from Japan, and is classified as Risk Class Kelas Resiko : C. 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 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
Feb 10, 2025
Expiry Date
Oct 26, 2027
Product Type
Clinical Chemistry Test System
Multi parameter clinical chemistry test system
Invitro Diagnostics
SPOTCHEM II STAT-1 (LDH, CPK, GPT/ALT, GOT/AST, Blood Urea Nitrogen, Total Bilirubin)
SPOTCHEM™ II Liver-1 (LDH, GPT/ALT, GOT/AST, Albumin, Total Protein, Total Bilirubin)
SPOTCHEM™ II HDL-Cholesterol (Direct Method)
SPOTCHEM ™ II CPK
SPOTCHEM™ II Amylase
SPOTCHEM II ALP
SPOTCHEM™ II Inorganic Phosphorus
SPOTCHEM™ II Uric Acid
SPOTCHEM II Blood Urea Nitrogen
SPOTCHEM ™ II GOT/AST
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 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.
SPOTCHEM II Blood Urea Nitrogen
ARKRAY FACTORY, INC.

