EU → North America Device Access

PROMOTAL

FR-MF-000001666 · France · Ernée

PROMOTAL is registered in the European database on medical devices as a manufacturer, with 105 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa105

Most frequent device types declared: APOLIUM, BX, DENEO, DUOLYS, Fauteuil ORL.

Among these devices, 58 are declared active.

Devices declared under this manufacturer

Showing 12 of 105 declared devices.

Catalogue references include 1981, 2800-30, 2863, 2981-01, 3060-40, 48010-01.

European nomenclature codes declared: V08020199, V08020101, V080202, V080299, V9099, V08050101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED105
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 GTIN105
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. PROMOTAL was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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