EU → North America Device Access

Caleres Europe Limitied

UK-MF-000050770 · United Kingdom · Milton Keynes

Caleres Europe Limitied is registered in the European database on medical devices as a manufacturer, with 131 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa131

Most frequent device types declared: Vasyli Accessories, Vasyli Orthotics.

Authorised representative in the Union: Nigel Kaufman.

Devices declared under this manufacturer

Showing 12 of 131 declared devices.

Catalogue references include 12H408_M_Red, 12RVR4_4D_Red, 71FB00_F/L_Blue, 71FG06_F/L_Green, 71HDF12_F/L_Grey, 71RR02_3/4_Red.

European nomenclature codes declared: Y061203.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED131
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 GTIN131
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. Caleres Europe Limitied was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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