FEI Numbers & DUNS Numbers
FDA Establishment Identifier (FEI)
When a facility registers with FDA, it is assigned an FEI (FDA Establishment Identifier) — a unique 10-digit number that identifies the registered facility. The FEI:
- Appears on establishment registration records
- Is referenced in FDA inspection records and warning letters
- Is used in 510(k) and PMA submissions to identify the manufacturing facility
- Is publicly searchable in FDA's establishment registration database
DUNS Number
A DUNS (Data Universal Numbering System) number is a 9-digit identifier assigned by Dun & Bradstreet. Some FDA systems (including certain electronic submissions) request a DUNS number for establishment identification. A DUNS number can be obtained free of charge from Dun & Bradstreet.
Finding your FEI
- Go to FDA's Establishment Registration and Device Listing database
- Search by establishment name, location, or FEI number