EU → North America Device Access

Edierre Implant System Srl

IT-MF-000027663 · Italy · Genova

Edierre Implant System Srl is registered in the European database on medical devices as a manufacturer, with 380 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa341
Class IIb39

Most frequent device types declared: COMPONENTE PROTESICO, COMPONENTI PROTESICI, Componenti chirurgici riutilizzabili destinati al posizionamento cont, Componenti protesici non impiantabili destinati alla riproduzione del, Dispositivo costituito da due parti: vite + corona che utilizzate ins.

Among these devices, 40 are declared sterile, 40 implantable, 138 reusable, 1 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 380 declared devices.

Catalogue references include P103711, P233700, P275005, P354501, P723300, P769033.

European nomenclature codes declared: P01020180, L15901199, Q010280, P01020101, L150101, L159016.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED380
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 GTIN380
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. Edierre Implant System Srl was not found in either the U.S. or the Canadian register.

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