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EUDAMED last updated this device on Apr 14, 2026
858600290172601NFN/A is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by GALVEX, spol. s r.o.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08586002902372858600290172601NFN/A(01)08586002902372
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.
Q030499OTOLOGY DEVICES - OTHER2 warnings recorded — scroll inside the panel to see all entries.
CW275CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Czechia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Jun 30, 2023 | Still on market |
SK-MF-000042324No 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.