Match the legal establishment name, city, state or province and country with the invoice, label and contract.
Independent public-data guide · not affiliated with FDA
FEI number lookup for medical device establishments.
Use the facility identifier a manufacturer, importer or supplier gave you to find the corresponding public device-establishment record before relying on the claim.
Quick answer
An FEI identifies a facility; it does not approve a device.
FDA describes the FEI as a facility identifier assigned by the agency. Use it to locate the establishment record and compare the legal name, location, registration number and activities. The FEI alone does not establish current device registration, device listing, clearance, authorization or approval.
What to compare after an FEI match
Review the status reported by the source, registration number, expiry year and every displayed establishment role.
Compare proprietary names and product evidence with the exact model being purchased; an establishment match is only the first step.
Data timing: FDADeviceCheck reads the latest available openFDA snapshot, which is updated monthly. Treat “active” as the source's reported status on the displayed dataset date and confirm time-sensitive decisions in the official FDA database.
How to check an FEI before a purchase
- Copy the full identifier exactly as supplied and preserve leading digits.
- Run the lookup and compare the returned facility name and location with the supplier's regulatory and commercial documents.
- Review the registration number, reported status, establishment roles and any device names available in the inspected records.
- Confirm the establishment in FDA's official Registration & Listing database and request device-specific evidence for the exact product.
Why an FEI can still require investigation
A trading company can provide the FEI of a separate manufacturer. Confirm the commercial relationship.
A record may identify a contract manufacturer, specification developer, relabeler or exporter rather than the role described by the supplier.
Depending on classification, the exact device may need separate 510(k), De Novo, PMA or exemption evidence.
FEI lookup questions
How do I look up an FEI number for a medical device facility?
Enter the 7–10 digit FEI in the lookup, compare the returned establishment name, location, registration number and roles with your supplier documents, then confirm the current record in FDA's official Registration & Listing database.
Does an FEI number mean a medical device is FDA approved?
No. An FEI identifies a facility for FDA purposes. It does not by itself prove that the facility has a current medical-device registration or that any specific device is listed, cleared, authorized or approved.
Is a no-match FEI result proof that the supplier is unregistered?
No. Check the digits, ask whether the supplier provided an FEI or another identifier, and search the official FDA source. Public data timing or a mismatch between the company and facility can also produce no match.