EU → North America Device Access

Eye Pharma S.p.a.

IT-MF-000026349 · Italy · Genova

Eye Pharma S.p.a. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Most frequent device types declared: Regenera Therapeutic Lens.

Among these devices, 6 are declared sterile.

Devices declared under this manufacturer

Catalogue references include A940223910, A941662633, A942891615, C940223910, C941662633, C942891615.

European nomenclature codes declared: Q02100499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. Eye Pharma S.p.a. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030167-00issued2030-12-21

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