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EUDAMED last updated this device on Apr 29, 2026
B-+EPIS43115N0SE-MF-000025702No 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.4 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW007CW032Primary placement in Germany; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jun 9, 2020 | Still on market |
| Belgium | Jul 1, 2022 | Still on market |
| Cyprus | May 31, 2022 | Still on market |
| Estonia | Oct 20, 2021 | Still on market |
| Spain | Oct 20, 2021 | Still on market |
| France | Jan 18, 2021 | Still on market |
| Italy | Oct 21, 2020 | Still on market |
| Norway | Mar 2, 2022 | Still on market |
| Poland | Sep 30, 2020 | Still on market |
| Portugal | May 9, 2022 | Still on market |
| Sweden | Oct 28, 2020 | Still on market |
+EPIS43115N0
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
P091399ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER