EU → North America Device Access

The SpineCorporation Limited

GB-MF-000001917 · United Kingdom · Chesterfield

The SpineCorporation Limited is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa24

Most frequent device types declared: Dynamic Corrective Brace, Dynamic Corrective Hybrid, Hyper Corrective Night Brace, LiteX Brace, Size 0.

Authorised representative in the Union: Ana del Campo Mateos.

Catalogue references include CMPLITEX, CMPNIGHT, SDCHYB, SF2, SF3, SF4.

European nomenclature codes declared: Y060399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTHE SPINECORPORATION LTD. (GB) · FDA 3003988753
Devices in EUDAMED24
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN24
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. The SpineCorporation Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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