EU → North America Device Access

SC MEDICA

FR-MF-000002722 · France · Strasbourg

SC MEDICA is registered in the European database on medical devices as a manufacturer, with 151 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa138
Class IIb13

Most frequent device types declared: DIVA, FFX.

Among these devices, 13 are declared sterile, 13 implantable, 134 reusable.

Devices declared under this manufacturer

Showing 12 of 151 declared devices.

Catalogue references include 57.006.XXE, 58.100.20, 58.100.30T, 58.100.50L, 58.EXX.XXL, 58.EXX.XXM.

European nomenclature codes declared: Z12130503, L26, L0999, L098099, P09070101, L091001.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySC MEDICA (FR) · FDA 3033557813
Devices in EUDAMED151
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN151
Found in the U.S. device database28
Share18.5 %

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. SC MEDICA is registered in the United States but was not found in the Canadian register.

Other manufacturers in France

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