EU → US Device Access

Gabbiano S.p.A.

IT-MF-000020347 · Italy · Cerese di Borgo Virgilio (MN)

Gabbiano S.p.A. is registered in the European database on medical devices as a manufacturer, with 69 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa61
Class IIb8

Most frequent device types declared: Cerotto Classico/ Apósito Clásico, FARMAMED Cerotto Bambini/Pansement Enfants/Aposito Infantil, Soletta fascite plantare 36/41, Coni Auricolari / Conos Auriculares, Benda Elastica/ Venda Elástica.

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 EUDAMED69
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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