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EUDAMED last updated this device on Jun 25, 2024
8050628388050628381076D2ITA 35 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by I.T.A.L. S.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080506283812438050628388050628381076D2ITA 35(01)08050628381243
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.
Y060399SPINE ORTHOSES - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW030No 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 | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| Estonia | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Hungary | Still on market | |
| Ireland | Still on market | |
| Iceland | Still on market | |
| Liechtenstein | Still on market | |
| Lithuania | Still on market | |
| Luxembourg | Still on market | |
| Latvia | Still on market | |
| Malta | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Sweden | Still on market | |
| Slovenia | Still on market | |
| Slovakia | Still on market | |
| Türkiye | Still on market | |
| XI | Still on market |
IT-MF-000039832No 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.