EU → North America Device Access

Farmigea S.p.A.

IT-MF-000018521 · Italy · Pisa

Farmigea S.p.A. is registered in the European database on medical devices as a manufacturer, with 42 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb38
Class IIa4

Most frequent device types declared: Carboxymethylcellulose 0.5% and 1% in single dose, multidose preservat, Dexpanthenol 5% gel, Hyaluronic acid 0.2% in multidose preservative free containers. Hyalur, Sodium Hyaluronate 0.4% multidose containers, Sodium Hyaluronate and TS-Polysaccharide in single dose and multidose .

Among these devices, 41 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 42 declared devices.

Catalogue references include 388, 389, 9000112, 9030379, 9030658-9031658, 9032308.

European nomenclature codes declared: Q02030206, Q02030201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED42
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 GTIN41
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. Farmigea S.p.A. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
CSQ001123issued2028-06-13
57320supplemented2030-03-11
56318issued2028-11-27
56317issued2028-11-27
56317reissued2028-11-27

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