CareStart™ Dengue IgM/IgG - Indonesia BPOM Medical Device Registration
CareStart™ Dengue IgM/IgG is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420411. The device is manufactured by ACCESS BIO KOREA, INC. from Korea, and is classified as Risk Class Kelas Resiko : C. 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
ACCESS BIO KOREA, INC.Country of Origin
Korea
Authorized Representative
PT. MEDISINDO BAHANAAR Address
GRAHA CEMPAKA MAS BLOK D No. 9 & Blok E NO.15 JL. LETJEN SUPRAPTO SUMUR BATU
Registration Date
Sep 02, 2024
Expiry Date
Jun 24, 2029
Product Type
Serological Reagents
Dengue virus serological reagents
Invitro Diagnostics
familyDr. BE5 Cartridges
SEAMATY DIAGNOSTIC CO., LTD.
family Dr. Uni Blood Glucose Monitoring System BSG01D-2
GENERAL LIFE BIOTECHNOLOGY CO., LTD.
family Dr.™ UA Uric Acid Test Strip
GENERAL LIFE BIOTECHNOLOGY CO., LTD.
FamilyDr Hemoglobin Test Strip
GENERAL LIFE BIOTECHNOLOGY CO.,LTD
familyDr.™ Blood Gas & Electrolyte Analyzer
SEAMATY DIAGNOSTIC CO., LTD.
familyDr. HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay)
AEHEALTH LIMITED
ROSSMAX Digital Thermometer
JOYTECH HEALTHCARE CO. LTD.
familyDr. MAU (Microalbumin) Rapid Quantitative Test (Immunofluorescence Assay)
AEHEALTH LIMITED
familyDr. BG3 Cartridges
SEAMATY DIAGNOSTIC CO., LTD.
P4Detect Dengue Combo
PRIME4DIA CO.,LTD

