EU → North America Device Access

Performance Health International LTD

GB-MF-000003319 · United Kingdom · Sutton-in-Ashfield, Nottinghamshire

Performance Health International LTD is registered in the European database on medical devices as a manufacturer, with 236 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa236

Most frequent device types declared: AIDS TO DAILY LIVING, BATHING & TOILETING, MOBILITY, ORTHOPEDICS.

Authorised representative in the Union: AR Experts B.V..

Devices declared under this manufacturer

Showing 12 of 236 declared devices.

Catalogue references include 081534684, 091097435, 091097468, 091098672, 091325711, 091357219.

European nomenclature codes declared: Y150912, Y181899, Y181803, Y091203, Y12030601, Y06120601.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPERFORMANCE HEALTH INTERNATIONAL LTD (GB) · FDA 9681624
Devices in EUDAMED236
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN234
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. Performance Health International LTD is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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