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EUDAMED last updated this device on Aug 4, 2025
8437013457Gentest004QRES-MF-000001005Primary placement in Spain; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Still on market | |
| Germany | Still on market | |
| France | Still on market | |
| Italy | Still on market | |
| Portugal | Still on market |
W02050192NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARENo 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.