EU → US Device Access

GN MED s.r.l.

IT-MF-000027922 · Italy · Ravenna

GN MED s.r.l. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb8
Class IIa1

Most frequent device types declared: LASERIX PH3, LASERIX PH12, DT-1004, PH10, Laserix PhP.

Among these devices, 8 are declared active.

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 EUDAMED9
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
ITH 2412060 1supplemented2028-11-15

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