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    Post-MarketPost-Market & SafetyGlobal MarketsGUDID

    Global Unique Device Identification Database

    FDA database holding key device identification information for all UDIs.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

    Definition

    GUDID is the U.S. publicly accessible database that contains the device identifier portion of UDIs along with attributes like brand name, version/model, sterilization, MR safety, and more. Labelers submit DI records through the GUDID web interface or via HL7 SPL files, and FDA publishes the data in AccessGUDID, run with the National Library of Medicine. Records include device identifiers, labeler, product codes, sizes, MR safety status and whether the device contains latex. Data must be kept current, and changes to certain attributes require a new DI. GUDID does not hold production identifiers such as lot or serial numbers.
    What the regulation says
    The FDA established GUDID as part of the UDI system under 21 CFR Part 830. This regulation mandates that medical device labelers submit specific device identification information to the GUDID. The primary purpose is to provide a comprehensive public database of medical devices distributed in the United States, facilitating their identification and traceability.

    What this means in practice

    Labelers submit GUDID records via FDA's portal or HL7 SPL. Data quality directly affects EHR ingestion, recall lookups, and supply chain integrity.

    Examples

    • A hospital uses the GUDID to confirm the manufacturer and model number of an implanted device during a patient follow-up appointment.
    • The FDA accesses GUDID during a recall event to quickly identify all affected devices and their key characteristics, streamlining communication to healthcare providers.
    • A supply chain manager integrates GUDID data into their inventory system to verify incoming medical devices against the official FDA database, improving inventory accuracy.
    Common pitfalls
    • •Failing to accurately link UDI-DI to correct device attributes can lead to submission rejection and compliance issues.
    • •Incorrectly submitting data, especially regarding device characteristics, can impair the utility of GUDID for post-market surveillance.
    • •Not understanding the distinction between device identifier (DI) and production identifier (PI) can result in improper data entry.
    • •Ignoring the ongoing maintenance requirements for GUDID records can lead to outdated information and non-compliance.
    • •Assuming GUDID is a global database and not recognizing it as specific to the US FDA’s regulatory framework often causes confusion.

    Frequently asked questions

    GUDID stores the device identifier (DI) part of the UDI, along with key static attributes such as the brand name, device description, version or model number, sterilization information, and MRI safety status. It does not contain production identifiers (PIs), which include lot or serial numbers.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 2Regulator guidance and consensus· 3
    Link health: 3 verified· last checked 2026-06-20
    FDA·2European Commission·1
    1. 1
      GUDID
      Tier 2 Verified
      FDAfda.gov
    2. 2
      FDA Recalls - Medical Devices
      Tier 2 Verified
      FDAfda.gov
    3. 3
      EUDAMED Public Site
      Tier 2 Verified
      European Commissionec.europa.eu

    Inline markers like [1] jump to the matching reference above.