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EUDAMED last updated this device on Feb 23, 2026
425120430200001020FCAST-Reagent Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Bruker Daltonics GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04251204327028425120430200001020FCE2-323-001(01)04251204327028
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W010403060101SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - MANUAL1 warning recorded — scroll inside the panel to see all entries.
CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
DE-MF-000024392No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.