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EUDAMED last updated this device on Mar 14, 2025
57144640-HI-00081-RLDK-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 | Aug 10, 2022 | Still on market |
| Austria | Aug 10, 2022 | Still on market |
| Belgium | Aug 10, 2022 | Still on market |
| Bulgaria | Aug 10, 2022 | Still on market |
| Cyprus | Aug 10, 2022 | Still on market |
| Czechia | Aug 10, 2022 | Still on market |
| Germany | Aug 10, 2022 | Still on market |
| Estonia | Aug 10, 2022 | Still on market |
| EL | Aug 10, 2022 | Still on market |
| Spain | Aug 10, 2022 | Still on market |
| Finland | Aug 10, 2022 | Still on market |
| France | Aug 10, 2022 | Still on market |
| Croatia | Aug 10, 2022 | Still on market |
| Hungary | Aug 10, 2022 | Still on market |
| Ireland | Aug 10, 2022 | Still on market |
| Italy | Aug 10, 2022 | Still on market |
| Lithuania | Aug 10, 2022 | Still on market |
| Luxembourg | Aug 10, 2022 | Still on market |
| Latvia | Aug 10, 2022 | Still on market |
| Malta | Aug 10, 2022 | Still on market |
| Netherlands | Aug 10, 2022 | Still on market |
| Poland | Aug 10, 2022 | Still on market |
| Portugal | Aug 10, 2022 | Still on market |
| Romania | Aug 10, 2022 | Still on market |
| Sweden | Aug 10, 2022 | Still on market |
| Slovenia | Aug 10, 2022 | Still on market |
| Slovakia | Aug 10, 2022 | Still on market |
(01)05714464088126
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y2145060201HEARING AID IN THE-EAR (ITE)