EU → North America Device Access

MEDESY srl

IT-MF-000028737 · Italy · Maniago

MEDESY srl is registered in the European database on medical devices as a manufacturer, with 2 019 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa2 019

Most frequent device types declared: DISPOSITIVI MEDICI PER USO ODONTOIATRICO, STRUMENTI CHIRURGICI RIUTILIZZABILI.

Among these devices, 2 019 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 2 019 declared devices.

Catalogue references include 4572/1, 6003/U1, 625/5-6.HL8, 633/8.HL8, 730/3C, 796/1.

European nomenclature codes declared: L1505, L159001, L150301, L159003, L159013, L15900699.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDESY srl (IT) · FDA 9680244
Devices in EUDAMED2 019
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN2 019
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: United States only. MEDESY srl is registered in the United States but was not found in the Canadian register.

Other manufacturers in Italy

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