EU → North America Device Access

DF MEDICA Oone srl

IT-MF-000028375 · Italy · APOLLOSA ( BN )

DF MEDICA Oone srl is registered in the European database on medical devices as a manufacturer, with 474 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa474

Among these devices, 24 are declared active.

Devices declared under this manufacturer

Showing 12 of 474 declared devices.

Catalogue references include DTSHT14, DTSHT1V17K, DTST080195, DTSTG16, FDTST01H23, FDTST05.

European nomenclature codes declared: V0899, V080702, V9099, Z120606, V08060101, V080302.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED474
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 GTIN474
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. DF MEDICA Oone srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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