EU → US Device Access

Ritter Concept GmbH

DE-MF-000006415 · Germany · Biberach

Ritter Concept GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa17

Most frequent device types declared: Dental Air Compressors, Dental Suction Systems, X-Ray Film developer Girardelli, Dental Power Systems.

Among these devices, 1 are declared sterile, 17 reusable, 17 active.

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 registerRegistered with FDA
Matched entryRITTER CONCEPT GMBH (DE) · FDA 3008813313
Devices in EUDAMED17
Country of registrationGermany

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