EU → North America Device Access

Sensor Medica Srl

IT-MF-000032343 · Italy · Guidonia Montecelio

Sensor Medica Srl is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa17

Most frequent device types declared: BASE 40x40, DYNAMIC 120x50, EXTREME 240x50, MAXI, MAXI 60x50.

Among these devices, 16 are declared active.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include DMFM2100, DMFM30050, DMFM4040, DMFMHDR50, DMHDR150, DMHDR200.

European nomenclature codes declared: Z12062603, Z11069001.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySensor Medica Srl (IT) · FDA 3009044218
Devices in EUDAMED17
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN17
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. Sensor Medica Srl is registered in the United States but was not found in the Canadian register.

Other manufacturers in Italy

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