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EUDAMED last updated this device on Dec 22, 2025
8437029703FOCUSEDON01EKES-MF-0000487341 warning recorded — scroll inside the panel to see all entries.
CW011Primary placement in Spain; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Still on market | |
| Germany | Still on market | |
| Italy | Still on market | |
| Netherlands | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market |
Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - 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.This device is not currently linked to any other device.