EU → North America Device Access

Gabel S.r.l.

IT-MF-000042288 · Italy · Rosà (Vicenza)

Gabel S.r.l. is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa18

Most frequent device types declared: Bastoncini da camminata riabilitativa serie \, Bastone da passeggio serie \, Bastoni da passeggio serie \, Supporto per disabilità serie \.

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include 700835250, 700848021, 700848029, 700848035, 700848044, 700848120.

European nomenclature codes declared: Y1299, Y120318, Y120315, Y12030601.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED18
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 GTIN18
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. Gabel S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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