EU → US Device Access

Edenta Etablissement

LI-MF-000011937 · Liechtenstein · Schaanwald

Edenta Etablissement is registered in the European database on medical devices as a manufacturer, with 3 343 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa3 343

Most frequent device types declared: 16670, 10521, 16412, 16411, 17761.

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 registerRegistered with FDA
Matched entryEDENTA ETABLISSEMENT (LI) · FDA 3003399707
Devices in EUDAMED3 343
Country of registrationLiechtenstein

Notified body certificates

CertificateStatusExpiry
1000183128issued2030-03-26

Other manufacturers in Liechtenstein

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