The FDA Establishment Identifier is assigned to a facility. An FEI can exist independently of a medical-device approval or clearance.
Independent public-data guide ยท not affiliated with FDA
Check the FDA number on a supplier document.
Determine whether the supplier gave you an FEI, establishment registration number or device listing number, then reconcile it with the company and facility in the official record.
Quick answer
A valid-looking number must resolve to the right establishment.
Enter the digits exactly as supplied, then compare the returned legal name, location, FEI, registration number and role with your transaction documents. A number that returns some FDA record does not prove that the seller is the manufacturer or that the exact device is cleared, approved or listed under that firm.
Know which identifier you received
An establishment identifier shown in device registration data. It can be separate from the FEI and still concerns the facility, not product approval.
A device-listing identifier. FDA says LST numbers are not directly searchable on a public website; obtain confirmation from the listing firm.
Important: FDA does not issue medical device registration certificates. A supplier-created certificate can help identify the claimed number, but it is not an official FDA document.
Red flags a number check can reveal
The number resolves to an establishment unrelated to the seller, manufacturer or facility named in the purchase file.
The returned country, facility or activity conflicts with what the supplier says it does.
The supplier presents an establishment number as if it were device-specific clearance or approval.
A practical registration-number workflow
- Preserve the original supplier document and copy the full number without altering leading digits.
- Ask the supplier to label the identifier: FEI, registration number, owner/operator number, device listing number or premarket number.
- Run the establishment lookup and compare the legal entity, facility location, roles and displayed identifiers.
- Resolve every mismatch before payment or shipment, then confirm the establishment and device evidence in official FDA sources.
Registration number questions
Is an FEI the same as an FDA registration number?
Not necessarily. Both identify establishment records and may sometimes display the same value, but FDA data can show a separate FEI and registration number. Match the returned legal entity and location instead of assuming the labels are interchangeable.
Can I search a device listing number, or LST, on a public FDA website?
FDA states that there is no public website for searching LST numbers directly. Ask the firm that listed the device to confirm the LST, and use the public Registration & Listing database to review releasable establishment and device information.
What should I do when no number match appears?
Check every digit, confirm which identifier the supplier provided, request the exact legal establishment name and search the official FDA database. A no-match result alone is not a final registration conclusion.