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EUDAMED last updated this device on Nov 7, 2025
06429810612SU001RQFI-MF-000008986Primary placement in Finland; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | Still on market | |
| France | Still on market | |
| Italy | Still on market |
W0202050392LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE06429810612BR005KGOn the marketAiforia® Clinical AI Model for Breast Cancer - HER206429810612BR004KEOn the marketAiforia® Clinical AI Model for Breast Cancer; ERB-06429810612038On the marketAiforia® Clinical AI Model for Breast Cancer; Ki67B-06429810612014On the marketAiforia® Clinical AI Model for Breast Cancer; PRB-06429810612045On the marketNo 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.