EU → North America Device Access

Suntech UK Limited

GB-MF-000025555 · United Kingdom · Reigate, Surrey

Suntech UK Limited is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Most frequent device types declared: Compass, HBLD3-D, Lite, MK1.5, STPC-A.

Among these devices, 5 are declared active.

Authorised representative in the Union: MedPath GmbH.

Devices declared under this manufacturer

Catalogue references include Compass, HBLD3-D, Lite, MK1.5, STPC-A.

European nomenclature codes declared: Y122124, Y122127.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySUNTECH UK LIMITED (GB) · FDA 3020640553
Devices in EUDAMED5
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN5
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. Suntech UK Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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