EU → US Device Access

bredent medical GmbH & Co. KG

DE-MF-000008125 · Germany · Senden

bredent medical GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 457 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb273
Class IIa184

Most frequent device types declared: abument, titanium, Dental implants, titanium, gingiva former, titanium, dental implant, zirconia, drill soft bone, steel.

Among these devices, 85 are declared sterile, 269 implantable, 128 reusable, 7 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 registerNot found in the FDA register
Devices in EUDAMED457
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.

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