GLUCOLINE Test Strip - Indonesia BPOM Medical Device Registration
GLUCOLINE Test Strip is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221349. The device is manufactured by YASEE BIOMEDICAL INC. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. HERMAN MEDTEK DIAGNOSTICS.
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
YASEE BIOMEDICAL INC.Country of Origin
China
Authorized Representative
PT. HERMAN MEDTEK DIAGNOSTICSAR Address
Jl. Lingkar Luar Barat, Puri Kembangan, Komplek Rukan Puri Mansion Blok A No.16 Kel.Kembangan Selatan Kec.Kembangan, Kota Jakarta Barat, DKI Jakarta
Registration Date
Aug 26, 2022
Expiry Date
Dec 31, 2025
Product Type
Clinical Chemistry Test System
Glucose test system (card)
Invitro Diagnostics
MDX Electroline 100 QC Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 Ca Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 K Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 QC Solution (Ca)
CARETIUM MEDICAL INSTRUMENT CO., LTD.
ELECTROLINE 100 Urine Diluent Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
ELECTROLINE 100 Reference Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 at Conditioner
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 pH Na Cl Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO.LTD.
ARIA Malaria Pf/Pan Ag Rapid Test
BEIJING GENESEE BIOTECH, INC
MDX Hemaline 500 Staining Solution
URIT MEDICAL ELECTRONIC CO., LTD.

