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EUDAMED last updated this device on Oct 9, 2025
3661690FOCALONE2ZFR-MF-0000022073 warnings recorded — scroll inside the panel to see all entries.
CW010CW016CW257Primary placement in Netherlands; available across 15 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Still on market | |
| Belgium | Still on market | |
| Germany | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Italy | Still on market | |
| Latvia | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Sweden | Still on market | |
| Türkiye | Still on market |
U99DEVICES FOR UROGENITAL SYSTEM - OTHERNo 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.