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EUDAMED last updated this device on Nov 26, 2021
B-08053677040093IT-MF-000017082Primary placement in Türkiye; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Jun 16, 2018 | May 25, 2024 |
| Austria | Jun 16, 2018 | May 25, 2024 |
| Belgium | Jun 16, 2018 | May 25, 2024 |
| Bulgaria | Jun 16, 2018 | May 25, 2024 |
| Cyprus | Jun 16, 2018 | May 25, 2024 |
| Czechia | Jun 16, 2018 | May 25, 2024 |
| Germany | Jun 16, 2018 | May 25, 2024 |
| Denmark | Jun 16, 2018 | May 25, 2024 |
| Estonia | Jun 16, 2018 | May 25, 2024 |
| EL | Jun 16, 2018 | May 25, 2024 |
| Spain | Jun 16, 2018 | May 25, 2024 |
| Finland | Jun 16, 2018 | May 25, 2024 |
| France | Jun 16, 2018 | May 25, 2024 |
| Croatia | Jun 16, 2018 | May 25, 2024 |
| Hungary | Jun 16, 2018 | May 25, 2024 |
| Ireland | Jun 16, 2018 | May 25, 2024 |
| Iceland | Jun 16, 2018 | May 25, 2024 |
| Italy | Jun 16, 2018 | May 25, 2024 |
| Liechtenstein | Jun 16, 2018 | May 25, 2024 |
| Lithuania | Jun 16, 2018 | May 25, 2024 |
| Luxembourg | Jun 16, 2018 | May 25, 2024 |
| Latvia | Jun 16, 2018 | May 25, 2024 |
| Malta | Jun 16, 2018 | May 25, 2024 |
| Netherlands | Jun 16, 2018 | May 25, 2024 |
| Norway | Jun 16, 2018 | May 25, 2024 |
| Poland | Jun 16, 2018 | May 25, 2024 |
| Portugal | Jun 16, 2018 | May 25, 2024 |
| Romania | Jun 16, 2018 | May 25, 2024 |
| Sweden | Jun 16, 2018 | May 25, 2024 |
| Slovenia | Jun 16, 2018 | May 25, 2024 |
| Slovakia | Jun 16, 2018 | May 25, 2024 |
| XI | Jun 16, 2018 | May 25, 2024 |
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.