--- title: "GUDID Definition & Meaning | MedTech Terms" description: "FDA database holding key device identification information for all UDIs. 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Global Unique Device Identification Database [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)GUDID # Global Unique Device Identification Database FDA database holding key device identification information for all UDIs. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 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](/terms/sterilization), MR safety, and more. What the regulation says The FDA established GUDID as part of the [UDI](/terms/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 - • Ignoring the ongoing maintenance requirements for GUDID records can lead to outdated information and non-compliance.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 What kind of information is stored in GUDID? GUDID stores the device identifier (DI) part of the [UDI](/terms/udi), along with key static attributes such as the brand name, device description, version or model number, [sterilization](/terms/sterilization) information, and MRI safety status. It does not contain production identifiers (PIs), which include lot or serial numbers. Who is responsible for submitting data to GUDID? How does GUDID support post-market activities? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Unique Device Identification(UDI) ](/terms/udi) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing UDI-DI vs. UDI-PI Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI. ](/terms/udi-di-pi)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 European Commission· 1 1. [1 GUDID Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/global-unique-device-identification-database-gudid) 2. [2 FDA Recalls - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) 3. [3 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Acronym GUDID Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=gudid) Learn in 60 seconds Card Lesson Quiz FDA database holding key device identification information for all UDIs. - · Labelers submit GUDID records via FDA's portal or HL7 SPL. - · Data quality directly affects EHR ingestion, recall lookups, and supply chain integrity. - · publicly accessible database that contains the device identifier portion of UDIs along with attributes like brand name, version/model, sterilization, MR safety, and more. Remember this Watch out: Failing to accurately link UDI-DI to correct device attributes can lead to submission rejection and compliance issues. Related terms - [Unique Device Identification(UDI) ](/terms/udi) - [UDI-DI vs. UDI-PI ](/terms/udi-di-pi) You may also need Auto-suggested from Post-Market and shared keywords. - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Customer Notification Letter ](/terms/customer-notification) - [Software Bill of Materials(SBOM) ](/terms/sbom) - [AI Act Prohibited Practices ](/terms/ai-act-prohibited-practices) - [Common Vulnerabilities and Exposures(CVE) ](/terms/cve) - [Health Information Sharing and Analysis Center(H-ISAC) ](/terms/h-isac) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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