EU → US Device Access

SCALEO MEDICAL

FR-MF-000002929 · France · Vailhauquès

SCALEO MEDICAL is registered in the European database on medical devices as a manufacturer, with 177 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa177

Most frequent device types declared: Passive and Active transfer slings, SHADO® shower trolley models 160, 180, 200, 240, 290 and 350, Poweo® Passive, Poweo active, Red line.

Among these devices, 79 are declared active.

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 EUDAMED177
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.

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