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The UDI directive requires transmission into and management of UDI related data into GUDID (Global Unique Device Identification Data Base), the FDA's global data base.
GUDID serves the registration of medical devices and related manufacturers' data. Any device registered can be accessed by the general public, as well as everybody concerned professionally. As a future option, GUDID is to be linked to other data bases around the world, strongly promoting global recognition.
Based on universal standards for medical device identification, the data base comprises a key set of identifying elements for each possible UDI coding.




For each Device Identifier (DI) (no PIs): Trade mark proprietor, trade/brand name of the device. And furthermore:


  applicable for new versions/models only: previous DI

  type/model Number

  applicable for directly marked devices only: DI other than indicated on type plate

  dimensions of type/model

  type of PI on type plate

  FDA premarket submission and listing number(s)

  Global Medical Device Nomenclature (GMDN) term

  FDA product code (procode)

  the number of individual devices in each package

  commercial distribution status

  higher levels of packaging

  indication whether it is a kit, combination product or HCT/P

Furthermore UDI provides information on the individual device marking it:


  as sterile or to be sterilised before use (nature and extent of sterilisation), advanced levels of packaging

  as containing natural rubber latex

  in respect of MRI compatibility (safe, conditional, unsafe)

  as Rx and/or OTC


Methods of dato submission:

  • Utilisation of the web tool
  • Upload as HL7 XML file, utilising available tools
  • Paid third party upload