EU → North America Device Access

SYSTEM ASSISTANCE MEDICAL

FR-MF-000003517 · France · LEDAT

SYSTEM ASSISTANCE MEDICAL is registered in the European database on medical devices as a manufacturer, with 766 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa766

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Showing 12 of 766 declared devices.

Catalogue references include P171MVPMHPNC, P311C40402HW, P361C48432HW, P471PM190, P501PA4046S, P514PA4040S.

European nomenclature codes declared: V08030102, V080702, T0399, V080302, T030502, R03010304.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED766
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN766
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. SYSTEM ASSISTANCE MEDICAL was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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