Medical Device
DUNS Request Assistance
Required for all FDA-registered medical device establishments — each physical facility must obtain a unique 9-digit DUNS Number to complete FDA Medical Device Establishment Registration under 21 CFR Part 807.
What Is a DUNS Number & Why Medical Device Establishments Must Have One
A DUNS Number (Data Universal Numbering System) is a unique 9-digit identifier issued by Dun & Bradstreet (D&B). The FDA requires every medical device establishment — both domestic and foreign — to obtain and list a valid DUNS Number as part of FDA Medical Device Establishment Registration and device listing requirements under 21 CFR Part 807.
FDA Registration Assistance manages every step of your establishment registration — from preparing and submitting your initial registration to renewing it annually and keeping your device listings current. Our specialists ensure your establishment remains compliant with 21 CFR Part 807 and fully authorized to market medical devices in the United States.
- Required for all foreign & domestic device establishments
- Each physical facility address needs its own DUNS Number
- No cost to obtain a DUNS Number from Dun & Bradstreet
- Must be listed in your FDA Establishment Registration
- FDA Registration Assistance manages the full DUNS process
Our Medical Device DUNS Request Assistance Services
Everything medical device manufacturers need to register and remain compliant with the FDA — from initial establishment registration and device listing to annual renewal and ongoing FDA compliance support, handled end-to-end by experienced FDA regulatory specialists.
DUNS Number Application
FDA Registration Assistance submits your DUNS Number request to Dun & Bradstreet — verifying your facility name, physical address, and ownership details to ensure a successful and accurate application.
Verification & Confirmation
We verify that your DUNS Number has been issued correctly and matches the physical facility address required for your FDA Medical Device Establishment Registration — preventing registration errors and delays.
FDA Registration Coordination
FDA Registration Assistance coordinates your DUNS Number directly with your FDA Establishment Registration filing — ensuring your facility identifier is accurately listed and your registration is fully compliant.
Compliance Guidance
Our regulatory team provides compliance guidance to prevent DUNS-related registration issues — including advice on multi-facility DUNS requirements and ongoing FDA registration maintenance.
Trusted FDA DUNS Request Assistance Specialists
Helping foreign and domestic medical device establishments obtain their DUNS Numbers quickly and accurately — ensuring compliant FDA registration year after year.
How Our Medical Device DUNS Request Assistance Service Works
A simple four-step process to get your medical device establishment registered and compliant with FDA requirements.
Submit Your Facility Details
Provide your facility name, physical address, and ownership information. FDA Registration Assistance reviews your establishment details and prepares your DUNS Number request for submission to Dun & Bradstreet.
DUNS Request Prepared & Submitted
FDA Registration Assistance compiles your facility information, prepares your complete DUNS Number application, and submits it to Dun & Bradstreet — ensuring accuracy and compliance with FDA requirements.
DUNS Number Issued & Verified
Once your DUNS Number is issued by Dun & Bradstreet, FDA Registration Assistance verifies it matches your facility address and confirms it is ready for use in your FDA Medical Device Establishment Registration.
FDA Registration Filed & Compliant
FDA Registration Assistance coordinates your verified DUNS Number directly into your FDA Establishment Registration filing — ensuring your facility is accurately registered, compliant, and legally authorized to market devices in the U.S.
Complete FDA Medical Device Compliance Solutions
We offer a full range of FDA medical device registration and compliance services — from DUNS Number assistance and establishment registration to device listing, U.S. Agent services, and annual renewals.
Medical Device Establishment Registration
Register your foreign or domestic medical device establishment with the FDA — required annually for all device manufacturers and distributors under 21 CFR Part 807.
Medical Device Listing
List your medical devices with the FDA alongside your establishment registration — required for all devices manufactured or distributed for the U.S. market.
Medical Device Labeling & Product Review
Ensure your medical device labels and product documentation meet FDA labeling requirements — reviewed by experienced FDA regulatory specialists.
Medical Device DUNS Request Assistance
Obtain your DUNS Number required for FDA Medical Device Establishment Registration — fast and accurate assistance to keep your registration on track.
Medical Device U.S. Agent Services
Designate FDA Registration Assistance as your official U.S. Agent — legally required for all foreign medical device establishments registering with the FDA.
Medical Device Listing Certificate
Obtain your official FDA Medical Device Listing Certificate confirming your device is registered and listed with the FDA — for clients, distributors, and partners worldwide.
QMS / cGMP Support
Establish and maintain your Quality Management System (QMS) and current Good Manufacturing Practices (cGMP) to meet FDA medical device quality requirements.
Medical Device Annual Establishment Renewal
Ensure your FDA Medical Device Establishment Registration is renewed on time every fiscal year — avoiding compliance gaps, enforcement risk, and marketing disruptions.
Import Alert & Device Detention Resolution
Get expert help resolving FDA medical device import alerts and detention notices — restoring your device's ability to enter U.S. commerce as quickly as possible.
Frequently Asked Questions — Medical Device DUNS Request Assistance
Find answers to the most common questions about FDA Medical Device Establishment Registration, annual renewal requirements, and how FDA Registration Assistance helps device companies stay compliant.
What is a DUNS Number?
A DUNS Number (Data Universal Numbering System) is a unique 9-digit identifier issued by Dun & Bradstreet (D&B). The FDA uses DUNS Numbers to identify and verify the physical location of medical device establishments required to register under 21 CFR Part 807.
Is a DUNS Number required for FDA Medical Device Establishment Registration?
Yes. All medical device establishments — both domestic and foreign — must have a valid DUNS Number listed in their FDA Medical Device Establishment Registration. Failure to provide a DUNS Number may result in registration cancellation.
Does the DUNS Number replace my FDA Establishment Registration?
No. The DUNS Number is a facility identifier used alongside your FDA registration — it does not replace it. You must still complete your full FDA Medical Device Establishment Registration and device listing as required under 21 CFR Part 807.
Who needs a DUNS Number for FDA purposes?
Any establishment that manufactures, packages, stores, labels, or distributes medical devices intended for the U.S. market must obtain a DUNS Number. This applies to both domestic and foreign facilities subject to FDA registration requirements.
Do multiple facility locations need separate DUNS Numbers?
Yes. Each physical facility address requires its own unique DUNS Number. If your company operates multiple manufacturing or distribution sites, each location must obtain and list its own DUNS Number in its respective FDA registration.
What happens if my establishment does not have a DUNS Number?
If your facility does not have a valid DUNS Number, the FDA may cancel your Medical Device Establishment Registration. This can prevent you from legally marketing or distributing devices in the U.S. and may result in enforcement action, import detentions, or compliance issues.
How long does it take to obtain a DUNS Number?
Standard DUNS Number requests typically take 1–5 business days through Dun & Bradstreet. FDA Registration Assistance submits your request promptly and follows up to ensure your number is issued and verified as quickly as possible.
Is there a cost to obtain a DUNS Number?
There is no charge from Dun & Bradstreet to obtain a DUNS Number. FDA Registration Assistance charges a one-time service fee of $399 to manage the complete DUNS request process on your behalf — including preparation, submission, verification, and FDA registration coordination.
Can I obtain a DUNS Number myself?
Yes, you can apply directly through Dun & Bradstreet's website. However, many companies prefer to use FDA Registration Assistance to ensure the DUNS Number is obtained correctly, verified promptly, and coordinated properly with their FDA Establishment Registration filing.
What information is needed to obtain a DUNS Number?
To obtain a DUNS Number, you will need to provide your legal business name, physical facility address (not a P.O. Box), contact information, and business type. FDA Registration Assistance reviews and verifies this information before submission to ensure accuracy.
Do I need a new DUNS Number for each FDA registration year?
No. A DUNS Number is issued once per physical facility address and does not expire or require annual renewal. However, your FDA Medical Device Establishment Registration must be renewed annually (October 1 – December 31 each year), and your DUNS Number must remain valid and accurate in your registration.
What if my facility address changes after obtaining a DUNS Number?
If your facility address changes, you must update your DUNS record with Dun & Bradstreet and update your FDA Establishment Registration accordingly. FDA Registration Assistance can assist with both the DUNS update and the FDA registration amendment to ensure ongoing compliance.
Does a foreign establishment need a DUNS Number for FDA registration?
Yes. All foreign medical device establishments that export devices to the U.S. market are required to have a valid DUNS Number as part of their FDA Medical Device Establishment Registration. The DUNS Number must reflect the actual physical address of the foreign facility.
Can FDA Registration Assistance handle the entire DUNS process?
Yes. FDA Registration Assistance manages the complete DUNS request process — from collecting your facility information and preparing the application to submitting it to Dun & Bradstreet, verifying the issued number, and coordinating it with your FDA Establishment Registration filing.
What is the relationship between a DUNS Number and FDA device listing?
Your DUNS Number must be listed in your FDA Medical Device Establishment Registration, which is required before or at the time of device listing. Without a valid DUNS Number in your establishment registration, your device listing cannot be completed and your devices cannot be legally marketed in the U.S.
How do I get started with FDA Registration Assistance DUNS support?
Simply complete the contact form on this page or reach out directly to FDA Registration Assistance. Provide your facility name, address, and any existing FDA registration details, and our team will begin preparing your DUNS Number request immediately.
Get Your Medical Device DUNS Number Today
Submit your facility details and FDA Registration Assistance will obtain your DUNS Number quickly and accurately — ensuring your establishment is fully compliant with FDA Medical Device Establishment Registration requirements under 21 CFR Part 807.
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