EU → North America Device Access

Prism Medical UK

GB-MF-000010634 · United Kingdom · Rhyl

Prism Medical UK is registered in the European database on medical devices as a manufacturer, with 471 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa471

Most frequent device types declared: Ceiling Track Hoist TX Advanced, Ceiling Track Hoist Transactive Xtra, Freeway Adjustable Height Shower trolley, 1900mm, standard, Freeway TA180, Freeway Wall Mounted Changing Table, 1900mm.

Authorised representative in the Union: Evolution Healthcare Ltd.

Devices declared under this manufacturer

Showing 12 of 471 declared devices.

Catalogue references include 12018A2430, 12018H1400, 12018H1520, 1201CA400MXLL, 1201CA700PMLL, 1201CA701HSPXXLL.

European nomenclature codes declared: V0805038002, V08050302, Y093312, V0805030102, Y093399, V0805030101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPRISM MEDICAL UK (GB) · FDA 3013318446
Devices in EUDAMED471
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN471
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: United States only. Prism Medical UK is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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