EU → US Device Access

AMBELIO

FR-MF-000001631 · France · La Mézière

AMBELIO is registered in the European database on medical devices as a manufacturer, with 55 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa55

Most frequent device types declared: Kit KNEEFREEZ PO, Kit Attelle Genou 3P FREEZSNOW® , Attelle de poignet pouce HandTbreizh , Ceinture de soutien lombaire Lumbar breizh, Attelle d'immobilisation du genou 3P Breizh Ortho® .

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 EUDAMED55
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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