EU → North America Device Access

lege artis Pharma GmbH + Co. KG

DE-MF-000006175 · Germany · Dettenhausen

lege artis Pharma GmbH + Co. KG is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Among these devices, 6 are declared implantable.

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include 0032301, 0032304, 0032306, 0032309, 0032310, 0032312.

European nomenclature codes declared: Q010199, A06010103, Q0101010299, D020102, Q0101010202, Q010204.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN28
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: Neither register. lege artis Pharma GmbH + Co. KG was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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