EU → North America Device Access

NOVACOR

FR-MF-000017735 · France · Rueil-Malmaison

NOVACOR is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Most frequent device types declared: Accessories Cuff systems.

Among these devices, 10 are declared active, 6 with a measuring function.

Devices declared under this manufacturer

Catalogue references include ACC-0103-04, ACC-0104-01, ACC-0106-21, ACC-0107-21, ACC-0210-00, ACC-0213-00.

European nomenclature codes declared: Z12050403.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN10
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. NOVACOR was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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