EU → US Device Access

Bruker Daltonics GmbH & Co. KG

DE-MF-000024392 · Germany · Bremen

Bruker Daltonics GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other46

Most frequent device types declared: Mueller-Hinton Broth, cation adjusted, MICRONAUT-H Medium , MBT HT Mycobacteria IVD Module, AST-Reagent Kit , MALDI Biotyper sirius IVD System.

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 entryBruker Daltonics (DE) · FDA 3010191749
Devices in EUDAMED46
Country of registrationGermany

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