EU → US Device Access

Evoluxion Health, Lda

PT-MF-000043932 · Portugal · Rio Maior

Evoluxion Health, Lda is registered in the European database on medical devices as a manufacturer, with 63 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa63

Most frequent device types declared: Bmotion Aluminium Wheelchair , Green Visco EvoVisco Anatomic EV815-Blue, GeliTech EvoGel Anatomic Pillow EV705, Bmotion Aluminium Wheelchair, Bwave Commode Chair 4-in-1 BW650.

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 EUDAMED63
Country of registrationPortugal
⚠️ 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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