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Basic UDI-DI information

On the next page, enter the Basic UDI-DI information:

EUDAMED basic udi-di information when registering a basic udi-di together with a udi-di for a system or procedure pack

  1. Choose a Risk Class from the drop-down list (the risk class must be the highest risk class of devices that are parts of the system or procedure pack):

    EUDAMED risk class field in the basic udi-di information step

  2. Fill in the indication of medical purpose and select the related language from the drop-down list.

    EUDAMED indication of medical purpose and language fields in the basic udi-di main information step

    If you add the indication in several languages, click on Add another indication of medical purpose and select its language.

    Select Yes or No if Device model is applicable and, if applicable, enter the Device model and a device name if there is one. Otherwise, enter only a Device name):

    EUDAMED device model applicable, device model and name fields in the basic udi-di information step

  3. Click on Save to save your registration as a draft and come back to it later, or click on Save & Next to save it as a draft and continue to the next steps:

    EUDAMED sava and save and next buttons