EU IVDR Kit Devices

View 3088 EU IVDR Kit devices on BEUDAMED, the Better Database on Medical Devices. Kits under the IVDR are in vitro diagnostic products composed of multiple components supplied together to perform a diagnostic function, such as reagent sets, controls, or calibrators. The BEUDAMED listing helps users identify market status, manufacturer details, and the declared intended use for each kit.

IVDR requirements for kits include demonstrated performance evaluation, appropriate labeling and instructions for use, and conformity assessment according to their risk class. Manufacturers must maintain technical documentation, implement post-market surveillance, and apply UDI where applicable to ensure traceability. Searching BEUDAMED entries for kits supports laboratories, clinicians, and procurement teams in confirming compliance and suitability for diagnostic workflows.