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Registration of a UDI-DI for an existing Basic UDI-DI of a Regulation Device

  1. On the EUDAMED Dashboard, select Manage your Basic UDI-DIs/ EUDAMED DIs:

    EUDAMED manage your basic udi-dis/eudamed dis link in the dashboard

  2. Filter the Basic UDI-DIs/ EUDAMED DIs in state Submitted or Registered:

    Important

    Additional UDI-DIs for a Basic UDI-DI can be added only for Regulation Devices (not for Legacy Devices).

    New UDI-DIs can be added only to Basic UDI-DIs that are in state Registered or Submitted:

    EUDAMED list of all registered or submitted basic udi-dis in the basic udi-dis/eudamed dis management page

  3. From the results, find the Basic UDI-DI for which you would like to add a new UDI-DI. Click on the three dots on the right and click on Add a new UDI-DI to this Basic UDI-DI:

    EUDAMED add a new udi-di to this basic udi-di link under the three dots in the basic udi-dis/eudamed dis management page

  4. Complete the series of steps required for the registration of a UDI-DI for an existing Basic UDI-DI ( UDI-DI identification information, UDI-DI Characteristics, Device information, Container Package Details):

    EUDAMED add new udi-di to existing basic udi steps

  5. When you have completed all steps, click on Submit my request to submit the new UDI-DI:

    EUDAMED submit my request button

    Important

    After Submitting the UDI-DI, the state of the UDI-DI will be:

    • Registered if the Basic UDI-DI has the state Registered;

    • Submitted if the Basic UDI-DI has the state Submitted.