EU → US Device Access

SOGEVA Srl

IT-MF-000026322 · Italy · Calolziocorte (LECCO)

SOGEVA Srl is registered in the European database on medical devices as a manufacturer, with 104 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa104

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 EUDAMED104
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
IT333749issued2029-07-08
0425-MDR-030027-00issued2028-05-10

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