EU → North America Device Access

MEGADENTA Dentalprodukte GmbH

DE-MF-000007420 · Germany · Radeberg

MEGADENTA Dentalprodukte GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Most frequent device types declared: Polymer-based dental restaurative material, light curing.

Among these devices, 5 are declared implantable.

Devices declared under this manufacturer

Catalogue references include 2MMH-51, 2MMH-52, 2MMH-53, 2MMH-54, 2MMH-55.

European nomenclature codes declared: Q01010103.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEGADENTA DENTALPRODUKTE GMBH (DE) · FDA 9680919
Devices in EUDAMED5
Country of registrationGermany

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. MEGADENTA Dentalprodukte GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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