EU → North America Device Access

steco-system-technik GmbH & Co. KG

DE-MF-000005648 · Germany · Hamburg

steco-system-technik GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa46

Most frequent device types declared: Titanmagnetics® Zubehör Positionierhilfe für Extrusionsmagnet.

Devices declared under this manufacturer

Showing 12 of 46 declared devices.

Catalogue references include M.27.01.D196L4, M.27.01.D225L4, M.27.02.D350, M.27.03.D150L6, M.27.03.D235, M.27.06.D210.

European nomenclature codes declared: P01020180, Q010499.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySTECO-SYSTEM-TECHNIK GMBH & CO. KG (DE) · FDA 9617660
Devices in EUDAMED46
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. steco-system-technik GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

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