Global Unique Device Identification Database (GUDID)

What is the GUDID?

GUDID is the reference catalog behind the U.S. UDI system: its records contain the device identifier (DI) and standardized attributes such as brand name, version or model, company, packaging levels and selected safety characteristics. Production identifiers such as lot, serial number and expiration date can appear in the UDI on the label but are not stored in GUDID.

Who must submit to GUDID, and when?

The labeler is responsible. FDA defines a labeler as a person who causes a label to be applied or modified with the intent that the device be commercially distributed without a later replacement or modification of that label; it is usually the manufacturer, but may instead be a specification developer, repackager, relabeler, kit assembler or single-use device reprocessor. An entity does not become the labeler merely because its distributor contact details are added without another label change. Applicable records must be submitted according to the UDI requirements and compliance dates.

Is GUDID public?

Yes — through AccessGUDID, which the FDA provides with the National Library of Medicine. Hospitals, registries, researchers, payers and patients can search it. Because those records are public, labelers need controlled processes for attribute accuracy, packaging relationships, publication timing and record updates rather than treating submission as a one-time data upload.

How does GUDID relate to UDI databases elsewhere?

Other jurisdictions, including the European Union through EUDAMED, have adopted UDI frameworks with their own data fields, assignment rules and timelines. A shared internal product-data model can support those submissions, but a GUDID record cannot simply be copied into another regulator's database. In the United States, GUDID submission remains distinct from establishment registration, device listing and any required premarket authorization.