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EUDAMED last updated this device on Jun 10, 2026
73500612300677711-1K is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Fogless International AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
2735006123013573500612300677711-1K(01)27350061230135
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.
R90060202PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE3 warnings recorded — scroll inside the panel to see all entries.
CW010CW262CW007No certificate specifically references this device's Basic UDI-DI.
Primary placement in Sweden; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| Iceland | Still on market | |
| Italy | Still on market | |
| Latvia | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market |
SE-MF-000001616No 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.