EU → US Device Access

NEW ANCORVIS SRL

IT-MF-000008879 · Italy · CALDERARA DI RENO (BO)

NEW ANCORVIS SRL is registered in the European database on medical devices as a manufacturer, with 5 505 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb4 561
Class IIa944

Most frequent device types declared: V4 System - V4 Base, Mbase Moncone , Link In Tibase, MUA (Multi Unit Abutment), Analogo - Analogue.

Among these devices, 4 561 are declared implantable, 155 reusable.

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 EUDAMED5 505
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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