EU → North America Device Access

elm-plastic GmbH

DE-MF-000005725 · Germany · Dudeldorf

elm-plastic GmbH is registered in the European database on medical devices as a manufacturer, with 761 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa761

Among these devices, 633 are declared with a measuring function.

Devices declared under this manufacturer

Showing 12 of 761 declared devices.

Catalogue references include 0314, 0466, 0492, 0537, 0768, 1810.01.91.

European nomenclature codes declared: A99, A070199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryELM-PLASTIC GMBH (DE) · FDA 3008801173
Devices in EUDAMED761
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN761
Found in the U.S. device database0
Share0.0 %

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. elm-plastic GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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