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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

  1. Go to FDA's Establishment Registration and Device Listing database
  2. Search by establishment name, location, or FEI number

Official resources