EU → US Device Access

ROLSELEY Limited

GB-MF-000022778 · United Kingdom · BRIGHTON

ROLSELEY Limited is registered in the European database on medical devices as a manufacturer, with 125 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa125

Most frequent device types declared: TNQ-T0A00, TNQ-T0B00, TNQ-T0C00, TNQ-T0D00, TNQ-T0K00.

Authorised representative in the Union: LT-AR-000049108.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED125
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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