EU → North America Device Access

Ondal Medical Systems GmbH

DE-MF-000000203 · Germany · Huenfeld

Ondal Medical Systems GmbH is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa34
Class IIb7

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Showing 12 of 41 declared devices.

Catalogue references include 04091591001087, AC 2000, CEMOR, CEMOR - Monitorträger Anschlusstücke, DB AC77/AC2000, MediLift.

European nomenclature codes declared: V9099, Z120309.

United States market access

FDA establishment registerRegistered with FDA
Matched entryONDAL MEDICAL SYSTEMS GMBH (DE) · FDA 3012272052
Devices in EUDAMED41
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN41
Found in the U.S. device database19
Share46.3 %

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. Ondal Medical Systems GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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