EU → North America Device Access

Pro 11 Wellbeing Limited

UK-MF-000046854 · United Kingdom · Wakefield

Pro 11 Wellbeing Limited is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa15

Most frequent device types declared: B00SPS6DJ6, B01BC80AZS, B079VRVSM1, B07B54CQS5, B07BJ2M4QL.

Authorised representative in the Union: Global E-commerce Experts Europe BV.

Catalogue references include B00SPS6DJ6, B079VRVSM1, B07B54CQS5, B07BJ2M4QL, B09L8MDF4Q, B09MFY3F55.

European nomenclature codes declared: Y061203, M03050299, M03040299, Y061218.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED15
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 GTIN15
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. Pro 11 Wellbeing Limited was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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