EU → North America Device Access

Dendia GmbH

AT-MF-000040359 · Austria · Feldkirch

Dendia GmbH is registered in the European database on medical devices as a manufacturer, with 2 264 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 264

Most frequent device types declared: Rotary Instruments.

Among these devices, 2 260 are declared reusable.

Catalogue references include 685204030522070, 806104001534025, 806104166524010, 806204249514012, 806204257504025, 806314204524020.

European nomenclature codes declared: Q0199, Q010399, L0916, L149009.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 264
Country of registrationAustria

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

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: Neither register. Dendia GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Austria

All Austria manufacturers →