EU → North America Device Access

preOx.RS GmbH

DE-MF-000005017 · Germany · Beselich

preOx.RS GmbH is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa38

Most frequent device types declared: ColonOx Darmrohr, Helicobacter Urease Test, IAP Adapter, Interpleuraler Analgesie Kathete, Interpleuraler Analgesie Katheter.

Among these devices, 28 are declared sterile, 2 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 46 declared devices.

Catalogue references include 100.025, 100.070, 100.071, 100.072, 508.124, 509.132.

European nomenclature codes declared: A0699, A020101, W0105090102, A070199, G020102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED46
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 GTIN46
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. preOx.RS GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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