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EUDAMED last updated this device on May 18, 2026
69449327FR01A16KAWelllead Multi-vent Mask is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Well Lead Medical Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0694493276780569449327FR01A16KAR01A07041F(01)06944932767805
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.
R03010202VENTURI MASKS1 warning recorded — scroll inside the panel to see all entries.
CW999No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Denmark | Still on market | |
| Estonia | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Hungary | Still on market | |
| Ireland | Still on market | |
| Iceland | Still on market | |
| Italy | Still on market | |
| Liechtenstein | Still on market | |
| Lithuania | Still on market | |
| Luxembourg | Still on market | |
| Latvia | Still on market | |
| Malta | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Sweden | Still on market | |
| Slovenia | Still on market | |
| Slovakia | Still on market | |
| Türkiye | Still on market | |
| XI | Still on market |
CN-MF-000006728No 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.69449327FF01C02EDOn the marketAll Silicone Foley Catheter with Temperature Sensor69449327FF01C02EDOn the marketAll Silicone Foley Catheter with Temperature Sensor69449327FF01C01EBOn the marketAll Silicone Foley Catheter with Temperature Sensor69449327FF01C02EDOn the marketAll Silicone Foley Catheter with Temperature Sensor69449327FF01C01EBOn the market