EU → North America Device Access

Scholl’s Wellness Company Limited

GB-MF-000034304 · United Kingdom · Kingston Upon Hull

Scholl’s Wellness Company Limited is registered in the European database on medical devices as a manufacturer, with 140 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa140

Authorised representative in the Union: Scholl's Welness company B.V..

Devices declared under this manufacturer

Showing 12 of 140 declared devices.

Catalogue references include 3073588, 3144616, 3144618, 3144620, 4000030, 9000077.

European nomenclature codes declared: Y061203, T0399, M030405.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySCHOLL'S WELLNESS COMPANY (US) · FDA 3015961134
Devices in EUDAMED140
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN140
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. Scholl’s Wellness Company Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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