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EUDAMED last updated this device on Jul 5, 2024
57144640-HI-00053-RB222095 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.
0571446400903957144640-HI-00053-RB222095(01)05714464009039
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.
Y2145060102BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)1 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 | Dec 16, 2020 | Still on market |
| Austria | Dec 16, 2020 | Still on market |
| Belgium | Dec 16, 2020 | Still on market |
| Bulgaria | Dec 16, 2020 | Still on market |
| Cyprus | Dec 16, 2020 | Still on market |
| Czechia | Dec 16, 2020 | Still on market |
| Germany | Dec 16, 2020 | Still on market |
| Estonia | Dec 16, 2020 | Still on market |
| EL | Dec 16, 2020 | Still on market |
| Spain | Dec 16, 2020 | Still on market |
| Finland | Dec 16, 2020 | Still on market |
| France | Dec 16, 2020 | Still on market |
| Croatia | Dec 16, 2020 | Still on market |
| Hungary | Dec 16, 2020 | Still on market |
| Ireland | Dec 16, 2020 | Still on market |
| Italy | Dec 16, 2020 | Still on market |
| Lithuania | Dec 16, 2020 | Still on market |
| Luxembourg | Dec 16, 2020 | Still on market |
| Latvia | Dec 16, 2020 | Still on market |
| Malta | Dec 16, 2020 | Still on market |
| Netherlands | Dec 16, 2020 | Still on market |
| Poland | Dec 16, 2020 | Still on market |
| Portugal | Dec 16, 2020 | Still on market |
| Romania | Dec 16, 2020 | Still on market |
| Sweden | Dec 16, 2020 | Still on market |
| Slovenia | Dec 16, 2020 | Still on market |
| Slovakia | Dec 16, 2020 | 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.