OPTICAL Q HbA1c - Indonesia BPOM Medical Device Registration
OPTICAL Q HbA1c is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207220182. 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
Dec 08, 2022
Expiry Date
Mar 02, 2027
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
OPTICAL Q D-Dimer
Optical Q CEA
OPTICAL Q PRL
OPTICAL Q Ferritin
OPTICAL Q beta-hCG
OPTICAL Q FSH
Optical Q TSH
OPTICAL Q Total T3
OPTICAL Q Free T4
OPTICAL Q Fluorimetric Immunoassay Analyzer
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