EU → US Device Access

Floy GmbH

DE-MF-000016503 · Germany · München

Floy GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8
Class IIb3

Most frequent device types declared: FloyBoneClassification, FloyOsteo, FloyBrain, FloyMammo.

Among these devices, 11 are declared active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
Country of registrationGermany
⚠️ 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.

Notified body certificates

CertificateStatusExpiry
SCAR-7.2.1.4amended2030-09-29
HZ 2369288-1cancelled2028-07-11

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