EU → North America Device Access

Ellegi Medical Optics S.r.l.

IT-MF-000041265 · Italy · Pozzuoli (NA)

Ellegi Medical Optics S.r.l. is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa12

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include C903P, C904, CT-2202C, LM-980, SLL-03, SLL-06.

European nomenclature codes declared: Z12120199, Z12120108, Q02100299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN12
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Ellegi Medical Optics S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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