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EUDAMED last updated this device on Mar 6, 2025
805384055COIZ12120199JX50.022.00 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by C.O.I. Compagnia Ottica Italiana srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08053840550121805384055COIZ12120199JX50.022.00(01)08053840550121
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.
Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
IT-MF-000021292No 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.