DYNAMIKER SARS-CoV-2 Ag Rapid Test - Indonesia BPOM Medical Device Registration
DYNAMIKER SARS-CoV-2 Ag Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303027226. The device is manufactured by DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SABA INDOMEDIKA.
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
DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTDCountry of Origin
China
Authorized Representative
PT. SABA INDOMEDIKAAR Address
KOMP.KEDOYA ELOK PLAZA KAV DB/33 KEDOYA SELATAN
Registration Date
Nov 17, 2021
Expiry Date
Jul 07, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
MECHATRONICS Starrsed NSTA
RR MECHATRONICS MANUFACTURING B.V.
SHIMADZU Digital Angiography System
SHIMADZU CORPORATION
COMBOSTIK 3 (Protein, pH, Glucose)
DFI CO., LTD.
COMBOSTIK โข R-300 and Accessories
DFI CO., LTD.
BIOGRAM ColorJet Nano
BIO-GRAM DIAGNOSTICS GMBH
COMBOSTIK R-600S and Accessories
DFI CO., LTD.
COMBOSTIK 10M (Blood, Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Nitrite, Leukocytes, pH, Specific Gravity)
DFI CO., LTD.
BIOGRAM JaClean
BIO-GRAM DIAGNOSTICS GMBH
BIOGRAM Safranin-FX JetDye-AF
BIO-GRAM DIAGNOSTICS GMBH
BIOGRAM Lugol's JetDye-AF
BIO-GRAM DIAGNOSTICS GMBH

