EU → US 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: Sodium Hyaluronate 0.4% multidose containers, Dexpanthenol 5% gel.

Among these devices, 41 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED42
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

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

Other manufacturers in Italy

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