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EUDAMED last updated this device on Sep 22, 2023
5905913529OPTUNIT8SPL-MF-000037042No 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 Poland; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | May 26, 2021 | Still on market |
| Czechia | May 26, 2021 | Still on market |
| Germany | May 26, 2021 | Still on market |
| EL | May 26, 2021 | Still on market |
| Italy | May 26, 2021 | Still on market |
| Romania | May 26, 2021 | Still on market |
| Slovakia | May 26, 2021 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12129001OPHTHALMOLOGICAL INSTRUMENT STANDS