familyDr. HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay) - Indonesia BPOM Medical Device Registration
familyDr. HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207420172. The device is manufactured by AEHEALTH LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEDISINDO BAHANA.
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
AEHEALTH LIMITEDCountry of Origin
United Kingdom
Authorized Representative
PT. MEDISINDO BAHANAAR Address
GRAHA CEMPAKA MAS BLOK D No. 9 & Blok E NO.15 JL. LETJEN SUPRAPTO SUMUR BATU
Registration Date
Oct 21, 2024
Expiry Date
Aug 01, 2028
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
FOKUS Auto 3-Diff Hematology Analyzer
FOKUS FDI HM-3 Plus Diluent Hematology Reagent
FOKUS FDI HM-5 Plus DIFF Lyse Hematology Reagent
FOKUS FDI HM-5 Plus Diluent Hematology Reagent
BM Diagnostics BM-C-5 LH Lyse Hematology Reagent
BM Diagnostics BM-C-5 Diluent Hematology Reagent
BM Diagnostics BM-C-5 Hematology Analyzer Cell Cleanser
BM Diagnostics BM-C-5 Diff Lyse Hematology Reagent
FOKUS FDI HM-5Plus LH lyse hematology reagent
BM Diagnostics BM-C-3 Lyse Hematology Reagent
familyDr. BE5 Cartridges
SEAMATY DIAGNOSTIC CO., LTD.
family Dr. Uni Blood Glucose Monitoring System BSG01D-2
GENERAL LIFE BIOTECHNOLOGY CO., LTD.
FamilyDr Hemoglobin Test Strip
GENERAL LIFE BIOTECHNOLOGY CO.,LTD
family Dr.™ UA Uric Acid Test Strip
GENERAL LIFE BIOTECHNOLOGY CO., LTD.
familyDr.™ Blood Gas & Electrolyte Analyzer
SEAMATY DIAGNOSTIC CO., LTD.
ROSSMAX Digital Thermometer
JOYTECH HEALTHCARE CO. LTD.
familyDr. MAU (Microalbumin) Rapid Quantitative Test (Immunofluorescence Assay)
AEHEALTH LIMITED
familyDr. BG3 Cartridges
SEAMATY DIAGNOSTIC CO., LTD.
CareStart™ Dengue IgM/IgG
ACCESS BIO KOREA, INC.
P4Detect Dengue Combo
PRIME4DIA CO.,LTD