EU → US 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
other8

Most frequent device types declared: Helicobacter Urease Test, Interpleuraler Spülkatheter, IAP Adapter, Thoraxkatheter PUR, Interpleuraler Analgesie Katheter .

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

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED46
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in Germany

All Germany manufacturers →