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EUDAMED last updated this device on May 12, 2026
B-06974677691776Influenza A/B virus Antigen Rapid Test Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shanghai BioGerm Medical Technology Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974677691776B-06974677691776IS-MY-015-5(01)06974677691776
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105099099VIROLOGY - RT & POC - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW011No certificate specifically references this device's Basic UDI-DI.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Still on market |
CN-MF-000018164No 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-06974677693619On the marketNipah virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)B-06974677693626On the marketEnterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)B-06974677693015On the marketEnterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)B-06974677693022On the marketEnterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)B-06974677693039On the market