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GUDID Database — Submitting & Maintaining

What is GUDID?​

The GUDID (Global Unique Device Identification Database) is the FDA database containing information about each device identifier (DI). Manufacturers must submit DI records to GUDID before marketing a device with UDI labelling.

What must be submitted to GUDID​

For each Primary DI, the submitter must provide:

  • Brand name
  • Version or model number
  • Company name
  • Labeller DUNS number
  • Device description
  • Device class (I/II/III)
  • 510(k)/PMA/De Novo number
  • Whether the device is sterile, latex-free, implantable, or a single-use device
  • MRI safety information
  • Applicable standards

How to submit​

Submissions to GUDID can be made via:

  • GUDID Web Interface — manual entry; suitable for small device portfolios
  • GUDID Bulk Upload — XML-based batch submission; for large portfolios
  • HL7 SPL (Structured Product Labelling) — for integration with enterprise systems

AccessGUDID — public search​

AccessGUDID (accessgudid.nlm.nih.gov) is the publicly searchable version of the GUDID, maintained by the National Library of Medicine. Anyone can search for device DI records.

Official resources​