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EUDAMED last updated this device on Aug 20, 2025
7350117580000000004YPSE-MF-000016895No 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 Sweden; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Dec 6, 2023 | Still on market |
| Germany | Dec 6, 2023 | Still on market |
| Denmark | Dec 6, 2023 | Still on market |
| Finland | Dec 6, 2023 | Still on market |
| France | Dec 6, 2023 | Still on market |
| Netherlands | Dec 6, 2023 | Still on market |
| Norway | May 6, 2024 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12059009ECG DATA MANAGEMENT SYSTEMS