EU → US Device Access

Fortuna Healthcare Limited

UK-MF-000048072 · United Kingdom · Enfield

Fortuna Healthcare Limited is registered in the European database on medical devices as a manufacturer, with 369 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa369

Most frequent device types declared: FTRGL, FTSNHK/EX100K/FTSN01/ EX1000, FT24EP/EW/EF/EB/EK, FT12C, FT1004.

Authorised representative in the Union: IE-AR-000044547.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED369
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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