EU → North America 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, Cerotto elastico con protezione batteriostatica / Apósito elástico con, Cerotto trasparente con protezione batteriostatica / Apósito transpare, Compressa di garza con protezione batteriostatica / Compresa de Gasa c, Coni Auricolari / Conos Auriculares.

Devices declared under this manufacturer

Showing 12 of 69 declared devices.

Catalogue references include 0432377, 0432384, 0432408, 0432414, 05317, 05323.

European nomenclature codes declared: M02030201,M0599, M0599, Y061203, M02030201, Q03040299, M0303010101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED69
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN69
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Gabbiano S.p.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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