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EUDAMED last updated this device on Jan 17, 2025
8053435666110A2SPEEDYZW66194.1 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by SIEM NOVA SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080534356600998053435666110A2SPEEDYZW66194.1(01)08053435660099
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120105SURGICAL MEDICAL ASPIRATORSNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jan 1, 2016 | Dec 31, 2049 |
| Austria | Jan 1, 2016 | Dec 31, 2049 |
| Belgium | Jan 1, 2016 | Dec 31, 2049 |
| Bulgaria | Jan 1, 2016 | Dec 31, 2049 |
| Cyprus | Jan 1, 2016 | Dec 31, 2049 |
| Czechia | Jan 1, 2016 | Dec 31, 2049 |
| Germany | Jan 1, 2016 | Dec 31, 2049 |
| Denmark | Jan 1, 2016 | Dec 31, 2049 |
| Estonia | Jan 1, 2016 | Dec 31, 2049 |
| EL | Jan 1, 2016 | Dec 31, 2049 |
| Spain | Jan 1, 2016 | Dec 31, 2049 |
| Finland | Jan 1, 2016 | Dec 31, 2049 |
| France | Jan 1, 2016 | Dec 31, 2049 |
| Croatia | Jan 1, 2016 | Dec 31, 2049 |
| Hungary | Jan 1, 2016 | Dec 31, 2049 |
| Ireland | Jan 1, 2016 | Dec 31, 2049 |
| Iceland | Jan 1, 2016 | Dec 31, 2049 |
| Liechtenstein | Jan 1, 2016 | Dec 31, 2049 |
| Lithuania | Jan 1, 2016 | Dec 31, 2049 |
| Luxembourg | Jan 1, 2016 | Dec 31, 2049 |
| Latvia | Jan 1, 2016 | Dec 31, 2049 |
| Malta | Jan 1, 2016 | Dec 31, 2049 |
| Netherlands | Jan 1, 2016 | Dec 31, 2049 |
| Norway | Jan 1, 2016 | Dec 31, 2049 |
| Poland | Jan 1, 2016 | Dec 31, 2049 |
| Portugal | Jan 1, 2016 | Dec 31, 2049 |
| Romania | Jan 1, 2016 | Dec 31, 2049 |
| Sweden | Jan 1, 2016 | Dec 31, 2049 |
| Slovenia | Jan 1, 2016 | Dec 31, 2049 |
| Slovakia | Jan 1, 2016 | Dec 31, 2049 |
| Türkiye | Jan 1, 2016 | Dec 31, 2049 |
| XI | Jan 1, 2016 | Dec 31, 2049 |
IT-MF-000034107No 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.