EU → North America Device Access

Skillbond Direct Limited

UK-MF-000057745 · United Kingdom · Slough

Skillbond Direct Limited is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa38

Most frequent device types declared: Metrowax.

Authorised representative in the Union: Advena SRL.

Devices declared under this manufacturer

Showing 12 of 38 declared devices.

Catalogue references include 1WAX2.5, 1WAX500, 4SAMPLE, 7WAX2.5, 8WAX20, GWAX500.

European nomenclature codes declared: Q010699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED38
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 GTIN38
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. Skillbond Direct Limited was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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