EU → US Device Access

Mediberg S.r.l. Unipersonale

IT-MF-000012712 · Italy · Calcinate

Mediberg S.r.l. Unipersonale is registered in the European database on medical devices as a manufacturer, with 436 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa429
Class IIb7

Most frequent device types declared: 306005GGZSME, 306004GGZSME, 306011GGZSME, 204122BAFSME, 306005GGBSME.

Among these devices, 162 are declared sterile, 6 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 EUDAMED436
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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