EU → North America Device Access

MDoloris Medical Systems SAS

FR-MF-000000421 · France · Loos

MDoloris Medical Systems SAS is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: ANI Sensor V1, ANI Sensor V1 PLUS, ANI Sensor V2, ANI-MR.

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Catalogue references include ART0073, ART0074, ART0076, ART0216, ART0237.

European nomenclature codes declared: C020501, Z12050703.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMDOLORIS MEDICAL SYSTEMS SAS

North American profile: Canada only. MDoloris Medical Systems SAS holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in France

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