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EUDAMED last updated this device on Jun 5, 2026
B-06974443200027SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shenzhen Reagent Technology Co., Ltd.. Placed on the EU market in Cyprus. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974443200027B-06974443200027RNS92131(01)06974443200027
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090699OTHER MULTIPLE PATHOGENS - RT & POC1 warning recorded — scroll inside the panel to see all entries.
CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Cyprus; available across 1 country total.
Placed on the market in Cyprus; per-country availability dates not published.
CN-MF-000047757No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-06974443200034On the marketEleven Respiratory Pathogens Antigen Rapid Test KitB-06974443201703On the marketEleven Respiratory Pathogens Antigen Rapid Test Kit （NPS)B-06974443200867On the marketHantavirus IgG/IgM Antibody Rapid Test KitB-06974443201826On the marketHantavirus IgG/IgM Antibody Rapid Test KitB-06974443201819On the market