FEI & DUNS Number Helper
Understand, validate, and look up FDA Establishment Identifiers (FEI) and DUNS numbers. Includes format validation and guidance.
What is an FEI Number?
An FDA Establishment Identifier (FEI) is a unique 10-digit number assigned by the U.S. Food and Drug Administration to identify facilities that manufacture, process, pack, or hold FDA-regulated products. Every facility that is registered with the FDA receives an FEI number, which is used across all FDA systems to track inspections, registrations, and compliance actions.
The FEI number is essential for facility registration, device listing, drug listing, and import/export operations involving FDA-regulated products.
How to Obtain an FEI Number
- Navigate to the FDA Unified Registration and Listing System (FURLS) portal.
- Create an account or log in to your existing FDA Industry Systems account.
- Complete your facility registration, including the facility name, address, and type of operations conducted.
- Once your registration is processed, the FDA assigns an FEI number to your establishment automatically.
- Your FEI number will appear on your registration confirmation and in the FURLS system.
FEI Format & Validation
FEI numbers are always exactly 10 numeric digits with no letters, dashes, or spaces. Example: 3002807169
Expected format: 10 numeric digits
Important Notes
- FEI numbers are assigned per establishment (physical location), not per company. A company with multiple facilities will have multiple FEI numbers.
- Annual registration renewal is required. Failure to renew can result in loss of your facility's active registration status.
- Foreign facilities exporting to the U.S. also receive an FEI and must designate a U.S. Agent.
Quick Reference Guide
When do I need an FEI?
- FDA facility registration (domestic and foreign)
- Medical device listing with the FDA
- Drug establishment registration and listing
- Food facility registration under the Bioterrorism Act
- Import and export operations involving FDA-regulated products
When do I need a DUNS?
- Certain FDA premarket submissions (e.g., 510(k), PMA)
- Federal grants and cooperative agreements
- Government contracts and procurement
- SAM.gov registration (required for federal business)
- Business credit reporting and vendor verification
FEI vs DUNS Comparison
| Feature | FEI Number | DUNS Number |
|---|---|---|
| Full Name | FDA Establishment Identifier | Data Universal Numbering System |
| Issued By | U.S. Food & Drug Administration | Dun & Bradstreet (D&B) |
| Format | 10 digits | 9 digits |
| Purpose | Identifies facilities in FDA systems | Identifies businesses globally |
| Cost | Free (assigned by FDA) | Free for federal registration purposes |
| Scope | FDA-regulated facilities only | All businesses worldwide |
| Renewal | Annual registration renewal required | No renewal; assigned permanently |
Disclaimer: This tool provides informational guidance about FEI and DUNS numbers for educational purposes. Format validation checks only the number structure (digit count) and does not verify whether a number is actually assigned or active. For official verification, please consult the FDA and Dun & Bradstreet directly. This tool does not constitute regulatory advice.
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