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FDA DUNS Number Requirement for Medical Device Establishments
The U.S. Food and Drug Administration (FDA) requires all medical device establishments to obtain a DUNS Number as part of FDA Medical Device Establishment Registration and listing requirements.
This requirement applies to both domestic and foreign medical device facilities involved in the manufacturing, packaging, storage, labeling, or distribution of medical devices intended for the U.S. market.
What Is a DUNS Number?
A DUNS Number (Data Universal Numbering System) is a 9-digit unique identifier issued by Dun & Bradstreet (D&B). The FDA uses the DUNS Number to identify and verify the physical location of a business facility.
Key points:
Each physical facility address must have its own DUNS Number
A DUNS Number does not replace your FDA Medical Device Establishment Registration
It allows the FDA to confirm that a medical device facility is legitimate and traceable
Why the FDA Requires a DUNS Number
The FDA uses DUNS Numbers to:
Verify the identity and location of medical device establishments
Strengthen supply chain transparency
Support inspections, oversight, and regulatory enforcement
Improve traceability of FDA-regulated facilities
Failure to obtain and properly list a DUNS Number may result in:
Cancellation of FDA Medical Device Establishment Registration
Delays in device listing or regulatory submissions
Increased compliance and enforcement risk
DUNS Number Assistance Services
FDA Registration Assistance provides professional support to help medical device companies obtain a DUNS Number quickly and correctly.
Our services include:
DUNS Number application assistance
Verification of company name and physical address
Coordination with FDA Medical Device Establishment Registration
Compliance guidance to prevent registration issues
If you would like FDA Registration Assistance to help your company obtain a DUNS Number, please contact us today.
Frequently Asked Questions (FAQ)
Is a DUNS Number required for FDA Medical Device Establishment Registration?
Yes. All medical device establishments must have a valid DUNS Number listed in their FDA registration.
Does the DUNS Number replace my FDA registration?
No. The DUNS Number is a separate identifier used to verify the physical facility. Your FDA registration remains required.
Who needs a DUNS Number?
Any facility that manufactures, packages, stores, labels, or distributes medical devices for the U.S. market.
Do multiple locations need separate DUNS Numbers?
Yes. Each physical facility address requires its own DUNS Number.
What happens if I do not obtain a DUNS Number?
Your FDA Medical Device Establishment Registration may be canceled, and you may be unable to legally market or distribute devices in the U.S.
Can FDA Registration Assistance handle the DUNS process for me?
Yes. FDA Registration Assistance manages the DUNS request process and ensures alignment with FDA requirements.
Contact FDA Registration Assistance
Ensure your medical device establishment remains compliant with FDA DUNS requirements.
