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EUDAMED last updated this device on Nov 26, 2021
B-08053677040116IT-MF-000017082Primary placement in Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Sep 26, 2019 | May 25, 2024 |
| Austria | Sep 26, 2019 | May 25, 2024 |
| Belgium | Sep 26, 2019 | May 25, 2024 |
| Bulgaria | Sep 26, 2019 | May 25, 2024 |
| Cyprus | Sep 26, 2019 | May 25, 2024 |
| Czechia | Sep 26, 2019 | May 25, 2024 |
| Germany | Sep 26, 2019 | May 25, 2024 |
| Denmark | Sep 26, 2019 | May 25, 2024 |
| Estonia | Sep 26, 2019 | May 25, 2024 |
| EL | Sep 26, 2019 | May 25, 2024 |
| Spain | Sep 26, 2019 | May 25, 2024 |
| Finland | Sep 26, 2019 | May 25, 2024 |
| France | Sep 26, 2019 | May 25, 2024 |
| Croatia | Sep 26, 2019 | May 25, 2024 |
| Hungary | Sep 26, 2019 | May 25, 2024 |
| Ireland | Sep 26, 2019 | May 25, 2024 |
| Iceland | Sep 26, 2019 | May 25, 2024 |
| Liechtenstein | Sep 26, 2019 | May 25, 2024 |
| Lithuania | Sep 26, 2019 | May 25, 2024 |
| Luxembourg | Sep 26, 2019 | May 25, 2024 |
| Latvia | Sep 26, 2019 | May 25, 2024 |
| Malta | Sep 26, 2019 | May 25, 2024 |
| Netherlands | Sep 26, 2019 | May 25, 2024 |
| Norway | Sep 26, 2019 | May 25, 2024 |
| Poland | Sep 26, 2019 | May 25, 2024 |
| Portugal | Sep 26, 2019 | May 25, 2024 |
| Romania | Sep 26, 2019 | May 26, 2024 |
| Sweden | Sep 26, 2019 | May 25, 2024 |
| Slovenia | Sep 26, 2019 | May 25, 2024 |
| Slovakia | Sep 26, 2019 | May 26, 2024 |
| Türkiye | Sep 26, 2019 | May 25, 2024 |
| XI | Sep 26, 2019 | May 25, 2024 |
(01)08053677040116
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHERNo 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.