Compare the legal establishment name and location returned for the FEI with the invoice, contract or label.
FDA establishment identifier
FEI number lookup for medical device facilities.
Use the identifier a manufacturer, importer or supplier gave you to find the corresponding public device-establishment record before you rely on the claim.
Quick answer
An FEI identifies a facility; it does not approve a device.
Paste the 7–10 digit number into the live lookup. Compare the establishment name, country, registration record and listed names with the supplier documents you hold. Registration is not FDA approval or clearance, so device-level authorization must be checked separately.
What the result helps you review
Review the registration record, establishment types and names present in the inspected openFDA result.
Use the result as a starting point, then confirm the record and any device-specific clearance in the official FDA source.
Important: a number that returns a facility does not prove that the exact product you plan to import is cleared, approved or compliant.
How to check an FEI before a purchase
- Copy the identifier exactly as supplied; do not remove leading digits.
- Run the lookup and compare the returned facility name and country with your supplier documents.
- Review the listed establishment context and note any missing or conflicting information.
- Verify the final record directly with FDA and request the device-specific regulatory reference when relevant.
FEI lookup questions
Can I search without an FEI?
Yes. The main tool also accepts a manufacturer or establishment name. Add the country when you need to narrow similar names.
Is a no-match result proof that the supplier is unregistered?
No. Check the number, legal name and source directly. A spelling issue, identifier mismatch or data timing can produce no match.