EU → North America 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: +Confort Square EV100, Bmotion Aluminium Wheelchair, Bwave Commode Chair 4-in-1 BW650, EcoSoft Ocular Cushion EV625, EcoSoft Round Pillow With Hole EV610.

Devices declared under this manufacturer

Showing 12 of 63 declared devices.

Catalogue references include AE.ALMO.9189, AE.ALMO.9194, AE.ALMO.9199, AE.ALMO.9200, AE.COLC.8097, CB.CADE.8089.

European nomenclature codes declared: V08030101, Y122103, Y093303, V080701, Y120606, Y093399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED63
Country of registrationPortugal

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN63
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. Evoluxion Health, Lda was not found in either the U.S. or the Canadian register.

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