EU → North America Device Access

PERSONUS Srl

IT-MF-000032051 · Italy · Milano

PERSONUS Srl is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa43

Most frequent device types declared: Hearing Aid, Hearing aid.

Among these devices, 43 are declared active.

Catalogue references include 3430, 3440, 3840P, SON3C, SON4E, SON7C.

European nomenclature codes declared: Y2145060203, Y2145060202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED43
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 GTIN43
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. PERSONUS Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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