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EUDAMED last updated this device on Jan 22, 2026
8406821BUG00253HBNO-MF-000000553No 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.2 warnings recorded — scroll inside the panel to see all entries.
CW027CW010Primary placement in Norway; available across 31 countries total.
| Country | On market since | Until |
|---|---|---|
| NorwayPrimary placement | Aug 26, 2022 | Still on market |
| Austria | Aug 26, 2022 | Still on market |
| Belgium | Aug 26, 2022 | Still on market |
| Bulgaria | Aug 26, 2022 | Still on market |
| Cyprus | Aug 26, 2022 | Still on market |
| Czechia | Aug 26, 2022 | Still on market |
| Germany | Aug 26, 2022 | Still on market |
| Denmark | Aug 26, 2022 | Still on market |
| Estonia | Aug 26, 2022 | Still on market |
| EL | Aug 26, 2022 | Still on market |
| Spain | Aug 26, 2022 | Still on market |
| Finland | Aug 26, 2022 | Still on market |
| France | Aug 26, 2022 | Still on market |
| Croatia | Aug 26, 2022 | Still on market |
| Hungary | Aug 26, 2022 | Still on market |
| Ireland | Aug 26, 2022 | Still on market |
| Iceland | Aug 26, 2022 | Still on market |
| Italy | Aug 26, 2022 | Still on market |
| Liechtenstein | Aug 26, 2022 | Still on market |
| Lithuania | Aug 26, 2022 | Still on market |
| Luxembourg | Aug 26, 2022 | Still on market |
| Latvia | Aug 26, 2022 | Still on market |
| Malta | Aug 26, 2022 | Still on market |
| Netherlands | Aug 26, 2022 | Still on market |
| Poland | Aug 26, 2022 | Still on market |
| Portugal | Aug 26, 2022 | Still on market |
| Romania | Aug 26, 2022 | Still on market |
| Sweden | Aug 26, 2022 | Still on market |
| Slovenia | Aug 26, 2022 | Still on market |
| Slovakia | Aug 26, 2022 | Still on market |
| XI | Aug 26, 2022 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11040102CARDIOLOGY ULTRASOUND SCANNERS