EU → US 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: B079VRVSM1, B09MFY3F55, B07B54CQS5, B0DK5K78RR, B09MFZTWHX.

Authorised representative in the Union: NL-AR-000038301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED15
Country of registrationUnited Kingdom
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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