FDA GUDID Compliance for Medical Devices—
Made Easy
Creating and submitting Unique Device Identifiers (UDIs) can be time-consuming and complex. Registrar Corp simplifies the process by helping medical device labelers comply with FDA UDI regulations and submit their data to the Global Unique Device Identification Database (GUDID).
2,000+ Medical Device Manufacturers Trust Registrar Corp
What Is a UDI?
A Unique Device Identifier (UDI) is a code used to track and identify medical devices. Labelers must submit UDI data to the FDA’s GUDID to ensure compliance with FDA regulations.
Two Components of a UDI:
Device Identifier (DI)
Fixed portion of the UDI
Identifies labeler and device version; issued by an FDA-accredited agency.
Product Identifier (PI)
Variable portion of the UDI
Includes variable data like expiration date, lot, or serial number.
Together, DI and PI ensure traceability through the device’s lifecycle.
How to Comply With UDI Requirements
FDA UDI compliance involves multiple steps, strict documentation, and timely submissions. Here are 5 steps you need to follow to be compliant with UDI and GUDID requirements:
Get a DUNS Number
Required for all device labelers.
Appoint a Regulatory Contact
Designate a point person for UDI submissions.
Collect UDIs
Assign unique UDIs for each model/version.
Identify GMDN Codes
Use correct global device classification codes.
Submit to GUDID
Ensure accurate data is submitted to FDA’s GUDID system.
Registrar Corp guides you through every step for smooth UDI compliance.
Submit Your UDIs With Registrar Corp
Managing UDI compliance for multiple devices can be overwhelming. Companies may need to submit hundreds or even thousands of UDIs at any given time. Registrar Corp streamlines this process for you with:
Regulatory Contact and Account
Coordinator Support
Guidance on Required Data and
Submission Process
Assistance in Requesting or
Obtaining a GUDID Account
UDI Submission to the
GUDID Database
One-on-One Expert Guidance
Throughout the Process
Need Help With UDI/GUDID Compliance?
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