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EUDAMED last updated this device on Jan 12, 2025
571473412042BCOrbis Hypodest 3 %, Sodium hypochlorite 3 %, 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 Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05714734120426571473412042BCR306915(01)05714734120426
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 Finland; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | Still on market | |
| Austria | Still on market | |
| Czechia | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| Estonia | Still on market | |
| Lithuania | Still on market | |
| Latvia | Still on market | |
| Netherlands | 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.