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EUDAMED last updated this device on Jun 4, 2026
858500J39794I3FF8585003403437 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by PROTETIKA, a.s.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08585003403437858500J39794I3FF8585003403437(01)08585003403437
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.
Y063099NON-EXTREMITY PROSTHESES - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW275No certificate specifically references this device's Basic UDI-DI.
Primary placement in Slovakia; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| SlovakiaPrimary placement | Still on market | |
| Czechia | Still on market | |
| Latvia | Still on market |
SK-MF-000004489No 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.