EU → North America Device Access

SIGVARIS SAS

FR-MF-000023834 · France · Saint Just Saint Rambert

SIGVARIS SAS is registered in the European database on medical devices as a manufacturer, with 3 018 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa3 018

Most frequent device types declared: Dynaven fin New 20-36 mmHg, Dynaven semi-opaque 20-36 mmHg, Sigvaris Active loisirs 15-20 mmHg, Sigvaris Essentiel coton 15-20 mmHg, Sigvaris Essentiel semi-transparent 15-20 mmHg.

Devices declared under this manufacturer

Showing 12 of 3 018 declared devices.

Catalogue references include 301730, 303154, 308090, 308193, 308266, 309196.

European nomenclature codes declared: M030405.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySIGVARIS AG (CH) · FDA 8031005
Devices in EUDAMED3 018
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN3 018
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. SIGVARIS SAS is registered in the United States but was not found in the Canadian register.

Other manufacturers in France

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