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EUDAMED last updated this device on Sep 25, 2025
8406821BUG00078HHFR-MF-0000006871 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 | Jan 13, 2025 | Still on market |
| Austria | Jan 13, 2025 | Still on market |
| Belgium | Jan 13, 2025 | Still on market |
| Bulgaria | Jan 13, 2025 | Still on market |
| Cyprus | Jan 13, 2025 | Still on market |
| Czechia | Jan 13, 2025 | Still on market |
| Germany | Jan 13, 2025 | Still on market |
| Denmark | Jan 13, 2025 | Still on market |
| Estonia | Jan 13, 2025 | Still on market |
| EL | Jan 13, 2025 | Still on market |
| Spain | Jan 13, 2025 | Still on market |
| Finland | Jan 13, 2025 | Still on market |
| Croatia | Jan 13, 2025 | Still on market |
| Hungary | Jan 13, 2025 | Still on market |
| Ireland | Jan 13, 2025 | Still on market |
| Iceland | Jan 13, 2025 | Still on market |
| Italy | Jan 13, 2025 | Still on market |
| Liechtenstein | Jan 13, 2025 | Still on market |
| Lithuania | Jan 13, 2025 | Still on market |
| Luxembourg | Jan 13, 2025 | Still on market |
| Latvia | Jan 13, 2025 | Still on market |
| Malta | Jan 13, 2025 | Still on market |
| Netherlands | Jan 13, 2025 | Still on market |
| Norway | Jan 13, 2025 | Still on market |
| Poland | Jan 13, 2025 | Still on market |
| Portugal | Jan 13, 2025 | Still on market |
| Romania | Jan 13, 2025 | Still on market |
| Sweden | Jan 13, 2025 | Still on market |
| Slovenia | Jan 13, 2025 | Still on market |
| Slovakia | Jan 13, 2025 | Still on market |
| Türkiye | Jan 13, 2025 | Still on market |
| XI | Jan 13, 2025 | Still on market |
Z11020492POSITRON EMISSION TOMOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARENo 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.