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EUDAMED last updated this device on Dec 15, 2025
57144640-HI-00052-R8DK-MF-000001270No 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.1 warning recorded — scroll inside the panel to see all entries.
CW010Primary placement in Denmark; available across 27 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Oct 27, 2025 | Still on market |
| Austria | Oct 27, 2025 | Still on market |
| Belgium | Oct 27, 2025 | Still on market |
| Bulgaria | Oct 27, 2025 | Still on market |
| Cyprus | Oct 27, 2025 | Still on market |
| Czechia | Oct 27, 2025 | Still on market |
| Germany | Oct 27, 2025 | Still on market |
| Estonia | Oct 27, 2025 | Still on market |
| EL | Oct 27, 2025 | Still on market |
| Spain | Oct 27, 2025 | Still on market |
| Finland | Oct 27, 2025 | Still on market |
| France | Oct 27, 2025 | Still on market |
| Croatia | Oct 27, 2025 | Still on market |
| Hungary | Oct 27, 2025 | Still on market |
| Ireland | Oct 27, 2025 | Still on market |
| Italy | Oct 27, 2025 | Still on market |
| Lithuania | Oct 27, 2025 | Still on market |
| Luxembourg | Oct 27, 2025 | Still on market |
| Latvia | Oct 27, 2025 | Still on market |
| Malta | Oct 27, 2025 | Still on market |
| Netherlands | Oct 27, 2025 | Still on market |
| Poland | Oct 27, 2025 | Still on market |
| Portugal | Oct 27, 2025 | Still on market |
| Romania | Oct 27, 2025 | Still on market |
| Sweden | Oct 27, 2025 | Still on market |
| Slovenia | Oct 27, 2025 | Still on market |
| Slovakia | Oct 27, 2025 | Still on market |
Y2145060101BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)