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EUDAMED last updated this device on Nov 7, 2025
643008145CSAFIB3YFI-MF-0000145403 warnings recorded — scroll inside the panel to see all entries.
CW999CW036CW999Primary placement in Finland; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Ireland | Still on market | |
| Italy | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Sweden | Still on market |
Z12050892CARDIAC TELEMETRY 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.