EU → North America Device Access

Roma Medical Aids

GB-MF-000013502 · United Kingdom · Bridgend

Roma Medical Aids is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa52

Most frequent device types declared: BASIC WALKING FRAME - NON-FOLDABLE, BATH BACK REST/SEAT, BATH BOARDS, COMMODE, MULTIPLE BASE WALKING STICK.

Authorised representative in the Union: StartDock Rotterdam B.V..

Catalogue references include 2012, 2111, 2474, 2474AM, 2512, 2513.

European nomenclature codes declared: Y120603, Y093303, V08020101, Y093399, Y120315, Y120606.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED52
Country of registrationUnited Kingdom

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

Device-level evidence

Devices with a numeric GTIN52
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. Roma Medical Aids was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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