EU → North America Device Access

One Health Vision

IT-MF-000030027 · Italy · Lecce

One Health Vision is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Alleniamo la memoria, BUILDATTENTION, LOGOQUIZ, NUMBERS' ADVENTURES, SCRIVO BENE.

Among these devices, 8 are declared active.

Devices declared under this manufacturer

Catalogue references include 04-TURBOLETTURA, 06-TUTTASCOLTO, 07-SCRIVO-B, 08-NUMBERS’ADVENTURES, 09-LOGOQUIZ, 10-BUILDATTENTION.

European nomenclature codes declared: V92.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. One Health Vision was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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