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EUDAMED last updated this device on Jun 11, 2026
B-27350061230180740-100K is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Fogless International AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
27350061230180B-27350061230180740-100K(01)27350061230180
European Medical Device Nomenclature — the EU product classification assigned to this device.
R040201TRACHEOSTOMY HUMIDIFIERSR900680PHONATION VALVES - ACCESSORIES2 warnings recorded — scroll inside the panel to see all entries.
CW010CW007No 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.C002238