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EUDAMED last updated this device on Oct 13, 2025
B-04260548935516DE-MF-0000097052 warnings recorded — scroll inside the panel to see all entries.
CW010CW014Primary placement in Germany; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Lithuania | Still on market | |
| Latvia | Still on market | |
| Netherlands | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Türkiye | Still on market |
Z12149005IMPEDANCE METERS FOR THE AUDITORY SYSTEMB-04260548936759On the marketCannula irrigation system, 110 mm0426054893CANZ8On the marketCannula irrigation system, 40 mm0426054893CANZ8On the marketCannula irrigation system, 80 mm0426054893CANZ8On the marketCombi 4000 (a combination of tympanometry and rhinomanometry)B-04260548935554On the marketNo 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.