EU → US Device Access

Alpha Solway Ltd

GB-MF-000019916 · United Kingdom · Annan

Alpha Solway Ltd is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa18

Most frequent device types declared: Sanity SP-2, H-3, 6020, HXC-3, HXL-3.

Authorised representative in the Union: IE-AR-000002785.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED18
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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