OPTICAL Q Fluorimetric Immunoassay Analyzer - Indonesia BPOM Medical Device Registration
OPTICAL Q Fluorimetric Immunoassay Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304220101. The device is manufactured by OPTIBIO.CO.,LTD from Korea, Democratic People's Republic Of, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. KIRANA JAYA LESTARI.
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
OPTIBIO.CO.,LTDCountry of Origin
Korea, Democratic People's Republic Of
Authorized Representative
PT. KIRANA JAYA LESTARIAR Address
JL. TANAH ABANG II NO. 37
Registration Date
Oct 13, 2022
Expiry Date
Mar 02, 2027
Product Type
Immunology Laboratory Equipment and Reagents
Immunofluorometer equipment
Invitro Diagnostics
OPTICAL Q D-Dimer
Optical Q CEA
OPTICAL Q Ferritin
OPTICAL Q PRL
OPTICAL Q FSH
OPTICAL Q beta-hCG
OPTICAL Q Total T3
OPTICAL Q Free T4
Optical Q TSH
OPTICAL Q HbA1c
HiLab Flow Ferritin
HI TECHNOLOGIES LTDA.
HiLab Flow bHCG FIA
HI TECHNOLOGIES LTDA.
WONTECH Air Gap Fiber
WONTECH CO., LTD.
MEDITHINQ Metascope
MEDITHINQ CO., LTD.
SEAMATY Cartridges for the Blood Gas & Electrolyte Analyser (pH, K+, Na+, Cl-, Ca2+)
CHENGDU POLYTECH BIOLOGICAL TECHNOLOGY CO., LTD
SEAMATY Cartridges for the Blood Gas & Electrolyte Analyser (pH, pO2, pCO2)
CHENGDU POLYTECH BIOLOGICAL TECHNOLOGY CO., LTD
PUSHKANG Coagulation 2 Test Panel
ZHEJIANG PUSHKANG BIOTECHNOLOGY CO.,LTD.
PUSHKANG Coagulation Control Abnormal
ZHEJIANG PUSHKANG BIOTECHNOLOGY CO.,LTD.
WONTECH Holinwon Prima Holmium Laser System
WONTECH CO., LTD.
HILAB Volt ALT
HI TECHNOLOGIES LTDA.

