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UDI-DI identification information

  1. Select the Issuing Entity from the drop-down and enter the UDI-DI code:

    EUDAMED issuing entity and udi-di code in udi-di identification step

    Important

    The UDI-DI code must be unique. If it already exists in EUDAMED, you will not be able to save.

    Note

    In the case of a GS1 Issuing Entity, the UDI-DI code you enter must be a 14-digit code including the check digit that will be used by EUDAMED to validate the UDI-DI code. If your GS1 UDI-DI (GTIN code) is shorter than 14 digits (check digit included), when populating EUDAMED field please add leading zero(s) until you reach 14 digits.

    For example:

    • 000000nnnnnnnn (GTIN-8)

    • 00nnnnnnnnnnnn (GTIN-12)

    • 0nnnnnnnnnnnnn (GTIN-13)

  2. Enter the Secondary UDI-DI from a different Issuing Entity to the UDI-DI if applicable:

    EUDAMED secondary udi-di from a different issuing entity in udi-di identification information page

  3. Enter the EMDN code, click Find and select the correct one from the list:

    EUDAMED emdn code field in udi-di identification information page

  4. If applicable, enter the trade name (as specified on the device label) and select its related language (select All languages if not language dependent):

    EUDAMED trade name and select the language fields when trade name applicable toggled to yes

  5. Enter the Reference/Catalogue number.

  6. Select the Type of ​UDI-PI​.

  7. Enter any additional pertinent information about the System or Procedure Pack, select the language of the additional information and enter a URL (web address) for additional information online, if applicable:

    EUDAMED additional product description and select the language fields

  8. Specify the UDI-DI status in selecting whether it is On the EU market, Not intended for the EU market or No longer placed on the EU market and click on Save or Save & Next:

    EUDAMED udi-di status field and save and save and next buttons