EU → North America Device Access

Otto Leibinger GmbH

DE-MF-000005525 · Germany · Muehlheim

Otto Leibinger GmbH is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa14

Among these devices, 14 are declared reusable.

Catalogue references include 110/0, 119/16, 119/17, 119/3B, 200/06, 215/6.

European nomenclature codes declared: L159003, L0399, L150799, L160201, L15900699.

United States market access

FDA establishment registerRegistered with FDA
Matched entryOTTO LEIBINGER GMBH (DE) · FDA 9614986
Devices in EUDAMED14
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN14
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. Otto Leibinger GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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