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EUDAMED last updated this device on Sep 25, 2025
8406821BUG00058HBFR-MF-000000687No 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.1 warning recorded — scroll inside the panel to see all entries.
CW010Primary placement in France; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Apr 22, 2021 | Still on market |
| Austria | Apr 22, 2021 | Still on market |
| Belgium | Apr 22, 2021 | Still on market |
| Bulgaria | Apr 22, 2021 | Still on market |
| Cyprus | Apr 22, 2021 | Still on market |
| Czechia | Apr 22, 2021 | Still on market |
| Germany | Apr 22, 2021 | Still on market |
| Denmark | Apr 22, 2021 | Still on market |
| Estonia | Apr 22, 2021 | Still on market |
| EL | Apr 22, 2021 | Still on market |
| Spain | Apr 22, 2021 | Still on market |
| Finland | Apr 22, 2021 | Still on market |
| Croatia | Apr 22, 2021 | Still on market |
| Hungary | Apr 22, 2021 | Still on market |
| Ireland | Apr 22, 2021 | Still on market |
| Iceland | Apr 22, 2021 | Still on market |
| Italy | Apr 22, 2021 | Still on market |
| Liechtenstein | Apr 22, 2021 | Still on market |
| Lithuania | Apr 22, 2021 | Still on market |
| Luxembourg | Apr 22, 2021 | Still on market |
| Latvia | Apr 22, 2021 | Still on market |
| Malta | Apr 22, 2021 | Still on market |
| Netherlands | Apr 22, 2021 | Still on market |
| Norway | Apr 22, 2021 | Still on market |
| Poland | Apr 22, 2021 | Still on market |
| Portugal | Apr 22, 2021 | Still on market |
| Romania | Apr 22, 2021 | Still on market |
| Sweden | Apr 22, 2021 | Still on market |
| Slovenia | Apr 22, 2021 | Still on market |
| Slovakia | Apr 22, 2021 | Still on market |
| Türkiye | Apr 22, 2021 | Still on market |
| XI | Apr 22, 2021 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11030692COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE