- Role
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EUDAMED last updated this device on May 8, 2026
805347039TIRESYAWBIT-MF-000007792Certificate health across this manufacturer's portfolio.
ITH 1450755 1Supplemented1 warning recorded — scroll inside the panel to see all entries.
CW010Primary placement in Italy; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | May 4, 2026 | Still on market |
| Austria | May 4, 2026 | Still on market |
| Cyprus | May 4, 2026 | Still on market |
| Germany | May 4, 2026 | Still on market |
| Spain | May 4, 2026 | Still on market |
| France | May 4, 2026 | Still on market |
| Ireland | May 4, 2026 | Still on market |
| Iceland | May 4, 2026 | Still on market |
| Liechtenstein | May 4, 2026 | Still on market |
| Luxembourg | May 4, 2026 | Still on market |
| Malta | May 4, 2026 | Still on market |
| Portugal | May 4, 2026 | Still on market |
| XI | May 4, 2026 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11031192SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE