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EUDAMED last updated this device on Jan 10, 2025
571473412041BAOrbis DentinOp EDTA-C 17%, 500 ml is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by DNTL Nordic ApS. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05714734120419571473412041BAMD174246(01)05714734120419
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.
Q010199CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Denmark; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Still on market | |
| Austria | Still on market | |
| Czechia | Still on market | |
| Germany | Still on market | |
| Finland | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Sweden | Still on market |
DK-MF-000013594No 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.