FDA – Medical Devices
DUNS Number Assistance
Fee: $99
Device labelers must obtain a DUNS number before entering product data in FDA’s GUDID database. The DUNS number is obtained from Dun & Bradstreet free of charge; FDA notes that the process can take up to 30 business days.
Who Is Obligated?
Companies that are the labeler of devices required to carry a UDI.
What We Do
- We check your company’s existing DUNS record and the accuracy of its details.
- If there is no DUNS number, we prepare and follow up on the application.
- We update the record when your address or company name changes.
What You Receive
- DUNS number
- Summary of the registered company information
DUNS Number Application
Company details required by Dun & Bradstreet so that we can obtain the DUNS number needed for FDA registrations on your company's behalf.
Frequently Asked Questions
- Why is a DUNS number required for medical devices?
- Device labelers must obtain a DUNS number before entering product data in FDA’s GUDID database.
- How long does it take to get a DUNS number?
- FDA notes that the process can take up to 30 business days. We therefore recommend applying before you start UDI preparation.
- Is there a charge for a DUNS number?
- The DUNS number is obtained from Dun & Bradstreet free of charge. Our fee is for preparing and following up on the application.
Sources: FDA: Prepare for GUDID.