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EUDAMED last updated this device on Sep 11, 2024
57144640-fSW-000011-25270477 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by SBO Hearing A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0571446413931657144640-fSW-000011-25270477(01)05714464139316
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y214599HEARING AIDS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Denmark; available across 27 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Aug 7, 2024 | Still on market |
| Austria | Aug 7, 2024 | Still on market |
| Belgium | Aug 7, 2024 | Still on market |
| Bulgaria | Aug 7, 2024 | Still on market |
| Cyprus | Aug 7, 2024 | Still on market |
| Czechia | Aug 7, 2024 | Still on market |
| Germany | Aug 7, 2024 | Still on market |
| Estonia | Aug 7, 2024 | Still on market |
| EL | Aug 7, 2024 | Still on market |
| Spain | Aug 7, 2024 | Still on market |
| Finland | Aug 7, 2024 | Still on market |
| France | Aug 7, 2024 | Still on market |
| Croatia | Aug 7, 2024 | Still on market |
| Hungary | Aug 7, 2024 | Still on market |
| Ireland | Aug 7, 2024 | Still on market |
| Italy | Aug 7, 2024 | Still on market |
| Lithuania | Aug 7, 2024 | Still on market |
| Luxembourg | Aug 7, 2024 | Still on market |
| Latvia | Aug 7, 2024 | Still on market |
| Malta | Aug 7, 2024 | Still on market |
| Netherlands | Aug 7, 2024 | Still on market |
| Poland | Aug 7, 2024 | Still on market |
| Portugal | Aug 7, 2024 | Still on market |
| Romania | Aug 7, 2024 | Still on market |
| Sweden | Aug 7, 2024 | Still on market |
| Slovenia | Aug 7, 2024 | Still on market |
| Slovakia | Aug 7, 2024 | Still on market |
DK-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.