EU → US Device Access

Helena Biosciences Europe

GB-MF-000028365 · United Kingdom · Gateshead

Helena Biosciences Europe is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other25

Most frequent device types declared: 200601, 200602, 3218, 201201, 201202.

Authorised representative in the Union: MT-AR-000000234.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED25
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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