EU → US Device Access

CREATION XXI

FR-MF-000012697 · France · Le Bouscat

CREATION XXI is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa33

Most frequent device types declared: STRAP4U ICE COMFORT S, STRAP4U-ATTELLE DE POUCE , STRAP4U, STRAP4U - STRAPPING DE POIGNET, STRAP4U ICE HOT HEALTH BAND S.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED33
Country of registrationFrance
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in France

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