EU → US Device Access

MED ITALIA BIOMEDICA S.R.L

IT-MF-000025272 · Italy · Genova

MED ITALIA BIOMEDICA S.R.L is registered in the European database on medical devices as a manufacturer, with 518 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa517
Class IIb1

Most frequent device types declared: CUSTOM KIT, CATETERE PER DRENAGGIO PERCUTANEO, DISPOSITIVI E ACCESSORI PER INFUSIONE E/O MONITORAGGIO, CUSTOM KIT (Componente), AGO PER PROCEDURE DIAGNOSTICHE E INTERVENTISTICHE.

Among these devices, 518 are declared sterile, 1 implantable.

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 EUDAMED518
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.

Other manufacturers in Italy

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