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EUDAMED last updated this device on Oct 20, 2025
6438147LifeCycle_8RCEJ4FI-MF-0000226206438147AutoDELFIA_PPP2On the marketAutoDELFIA Automatic Immunoassay System6438147AutoDELFIA_PPP2On the marketAutoDELFIA Free hCGßB-06438147009695On the marketAutoDELFIA hAFPB-06438147129980On the marketAutoDELFIA hAFP/Free hCGß DualB-06438147009602On the marketNo 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 Finland; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | Oct 17, 2025 | Still on market |
| Austria | Oct 17, 2025 | Still on market |
| Belgium | Oct 17, 2025 | Still on market |
| Bulgaria | Oct 17, 2025 | Still on market |
| Cyprus | Oct 17, 2025 | Still on market |
| Czechia | Oct 17, 2025 | Still on market |
| Germany | Oct 17, 2025 | Still on market |
| Denmark | Oct 17, 2025 | Still on market |
| Estonia | Oct 17, 2025 | Still on market |
| EL | Oct 17, 2025 | Still on market |
| Spain | Oct 17, 2025 | Still on market |
| France | Oct 17, 2025 | Still on market |
| Croatia | Oct 17, 2025 | Still on market |
| Hungary | Oct 17, 2025 | Still on market |
| Ireland | Oct 17, 2025 | Still on market |
| Iceland | Oct 17, 2025 | Still on market |
| Italy | Oct 17, 2025 | Still on market |
| Liechtenstein | Oct 17, 2025 | Still on market |
| Lithuania | Oct 17, 2025 | Still on market |
| Luxembourg | Oct 17, 2025 | Still on market |
| Latvia | Oct 17, 2025 | Still on market |
| Malta | Oct 17, 2025 | Still on market |
| Netherlands | Oct 17, 2025 | Still on market |
| Norway | Oct 17, 2025 | Still on market |
| Poland | Oct 17, 2025 | Still on market |
| Portugal | Oct 17, 2025 | Still on market |
| Romania | Oct 17, 2025 | Still on market |
| Sweden | Oct 17, 2025 | Still on market |
| Slovenia | Oct 17, 2025 | Still on market |
| Slovakia | Oct 17, 2025 | Still on market |
| Türkiye | Oct 17, 2025 | Still on market |
| XI | Oct 17, 2025 | Still on market |
W02079092VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE