GENRUI SARS-CoV-2 Antigen Test Kit (Colloidal Gold) - Indonesia BPOM Medical Device Registration
GENRUI SARS-CoV-2 Antigen Test Kit (Colloidal Gold) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303120671. The device is manufactured by GENRUI BIOTECH INC from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is GLOBAL SYSTECH MEDIKA.
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
GENRUI BIOTECH INCCountry of Origin
China
Authorized Representative
GLOBAL SYSTECH MEDIKAAR Address
Jl. TB Simatupang No.17 RT.011/002 Kel. Susukan, Kec. Ciracas Jakarta Timur
Registration Date
Jan 10, 2022
Expiry Date
Dec 19, 2024
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
ARUMAMED Electrolyte Reagent A-Lyte-1
EAGLECARE EL-P20 Protein Analyzer
ARUMAMED Electrolyte Analyzer A-Lyte 500 Plus
ARUMAMED DILUENT 5-DIFF
ARUMAMED LD LYSE 5-DIFF
ARUMAMED LD LYSE 5-PART
ARUMAMED LH LYSE 5-DIFF
ARUMALAB LH LYSE ON 580
ARUMALAB LD LYSE ON 580
ARUMALAB AR 580 Hematology Analyzer
TOSAN Infant Transport Incubators
TOSAN CO.
TOSAN Infant Phototherapy
TOSAN CO.
OSCIMED ERGO II Cast Cutter Saw
OSCIMED SA
KINETEC Knee Continuous Passive Motion Machine
KINETEC SAS.
KINETEC Shoulder CPM Machine
KINETEC SAS
KINETEC Knee Continuous Passive Motion Machine
KINETEC SAS.
KINETEC Centura Environment Shoulder & Elbow CPM Machine
KINETEC SAS.
CHARMCARE Pulse Oximeter
CHARMCARE CO,LTD
ADC Mobile Aneroid Sphygmomanometer 752M
AMERICA DIAGNOSTIC CORPORATION.
ADC Clock Wall Aneroid Sphygmomanometer 750W
AMERICA DIAGNOSTIC CORPORATION.

