EU → US Device Access

BioFynder Limited

UK-MF-000047512 · United Kingdom · Southampton

BioFynder Limited is registered in the European database on medical devices as a manufacturer, with 134 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other134

Most frequent device types declared: TH100, TC600, TA100, TG100, TX100.

Authorised representative in the Union: NL-AR-000000247.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED134
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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