U.S. FDA UDI Application Service
Support for UDI preparation, identifier creation and GUDID-related data submission for medical devices entering the U.S. market. The service can include identifier-system setup, device data organization and database-entry support.
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Service Overview
EXIMIO supports manufacturers preparing Unique Device Identification (UDI) information for the U.S. market. The source workflow covers identifier-system membership, device identifier creation, GUDID account setup, GMDN-code preparation and final device-data entry.
Process Flow & Timing
Select a route below to view the workflow and timing.
UDI / GUDID Support
Indicative project timeline2–4 weeksSource estimate; not statutory
UDI Application
Apply for GS1 Membership
Membership Certificate / Prefix
Create Device Identifier (DI)
Apply for GUDID CRD Account
Apply for GUDID IDE Account
Complete GUDID IDE Account
Confirm GMDN Code
Enter Device Data into GUDID
UDI Setup Complete
Regulatory Basis & Official References
Legal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.
Law21 CFR Part 801Medical-device labeling requirements, including UDI-related labeling provisions.Open official source ↗Law21 CFR Part 830Unique Device Identification requirements and GUDID framework.Open official source ↗Official GuidanceFDA UDI BasicsOfficial FDA overview of the UDI system and core obligations.Open official source ↗Official GuidanceFDA Global UDI Database (GUDID)Official FDA GUDID information and submission resources.Open official source ↗
Related Regulatory Support
FDA device listing and premarket submission support can be coordinated with UDI work where needed.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.