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EUDAMED last updated this device on May 15, 2026
B-06975447582249106-0141-01 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Igenesis(Shanghai)Co.,Ltd.. Placed on the EU market in Greece. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06975447582249B-06975447582249106-0141-01(01)06975447582249
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104080602NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSANo certificate specifically references this device's Basic UDI-DI.
Primary placement in EL; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ELPrimary placement | Still on market |
CN-MF-000001552No 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.