EU → North America Device Access

ReDent Nova GmbH & Co. KG

DE-MF-000032545 · Germany · Berlin

ReDent Nova GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: SAF.

Among these devices, 9 are declared sterile, 1 reusable, 4 active.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include B-SA-CRD-00-000-000-0890, B-SA-IMC-00-000-000-0839, B-SA-IMC-00-000-000-0888, MFC-10-000-000-0065, SF-10-150-021-0057, SF-10-200-021-0060.

European nomenclature codes declared: Q010507, Z12110199, Q010599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
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 GTIN16
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryREDENT NOVA LTD.

North American profile: Canada only. ReDent Nova GmbH & Co. KG holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Germany

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