EU → North America 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: 10521, 11341, 16202, 16411, 16412.

Devices declared under this manufacturer

Showing 12 of 3 343 declared devices.

Catalogue references include 0533RA-100, 0659HP-100, 1.204.040, 174.21.654.060, C31.204.010, G801.316.016.

European nomenclature codes declared: Z12110102, L159007, Q01010403, L159004, Q010105, Q010501.

United States market access

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

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Edenta Etablissement is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
1000183128issued2030-03-26

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