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EUDAMED last updated this device on Feb 20, 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 | Nov 19, 2025 | Still on market |
| Austria | Nov 19, 2025 | Still on market |
| Cyprus | Nov 19, 2025 | Still on market |
| Germany | Nov 19, 2025 | Still on market |
| Spain | Nov 19, 2025 | Still on market |
| France | Nov 19, 2025 | Still on market |
| Ireland | Nov 19, 2025 | Still on market |
| Iceland | Nov 19, 2025 | Still on market |
| Liechtenstein | Nov 19, 2025 | Still on market |
| Luxembourg | Nov 19, 2025 | Still on market |
| Malta | Nov 19, 2025 | Still on market |
| Portugal | Nov 19, 2025 | Still on market |
| XI | Nov 19, 2025 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11031192SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE