EU → North America Device Access

LAZELEC

FR-MF-000007150 · France · Talmont Saint Hilaire

LAZELEC is registered in the European database on medical devices as a manufacturer, with 160 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa160

Most frequent device types declared: Mobile Dream.

Among these devices, 160 are declared active.

Devices declared under this manufacturer

Showing 12 of 160 declared devices.

Catalogue references include Mobile Dream standard abdominale gachette droite bleu, Mobile Dream standard harnais gachette droite jaune, Mobile Dream standard harnais poignée tournante gauche orange, Mobile Dream tablettes de transfert abdominale gachette droite violet, Mobile Dream tablettes de transfert abdominale gachette gauche noir, Mobile Dream tablettes de transfert abdominale gachette gauche rouge.

European nomenclature codes declared: Y122199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED160
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 GTIN160
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. LAZELEC was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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