EU → US Device Access

iVis Technologies S.r.l.

IT-MF-000016859 · Italy · Taranto

iVis Technologies S.r.l. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb11
Class IIa2

Most frequent device types declared: CX001, VX001, OX0001, DX001, NX001.

Among these devices, 5 are declared sterile, 3 implantable, 8 active, 3 with a measuring function.

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 EUDAMED13
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.

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