ADAMS A1c Lite HA-8380V - Indonesia BPOM Medical Device Registration
ADAMS A1c Lite HA-8380V is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207420004. 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, INC.Country of Origin
Philippines
Authorized Representative
PT. ARKRAYAR Address
Gedung Mega Plaza Lt. 12, Jl. HR. Rasuna Said Kav. C - 3
Registration Date
May 09, 2024
Expiry Date
Oct 26, 2027
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
SPOTCHEMโข II HDL-Cholesterol (Direct Method)
ARKRAY FACTORY, INC.
SPOTCHEMโข 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 โข II CPK
ARKRAY FACTORY, INC.
SPOTCHEMโข II Amylase
ARKRAY FACTORY, INC.
SPOTCHEM II ALP
ARKRAY FACTORY, INC.
SPOTCHEMโข II Inorganic Phosphorus
ARKRAY FACTORY, INC.
COBIO S50 Fully Automated Urine Sediment Analyzer
COBIO SMART HEALTHCARE TECHNOLOGY CO., LTD.
SPOTCHEMโข II Uric Acid
ARKRAY FACTORY, INC.

