EU → North America Device Access

LUKAS-ERZETT GmbH & Co.KG

DE-MF-000005344 · Germany · Engelskirchen

LUKAS-ERZETT GmbH & Co.KG is registered in the European database on medical devices as a manufacturer, with 192 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa192

Devices declared under this manufacturer

Showing 12 of 192 declared devices.

Catalogue references include 307134210, 307136710, 35609, 35650, 35661, 35684.

European nomenclature codes declared: V0199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLUKAS-ERZETT GMBH & CO. KG (DE) · FDA 3013247796
Devices in EUDAMED192
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN192
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. LUKAS-ERZETT GmbH & Co.KG is registered in the United States but was not found in the Canadian register.

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