The number resolves to an establishment that is not the seller, manufacturer or facility named in your file.
Supplier number review
Check an FDA registration number before you import.
Use the number on a certificate, quote or supplier profile to find the public establishment record and confirm that it points to the company you are actually buying from.
Quick answer
The number must resolve to the same establishment, not merely to any FDA record.
Enter the digits exactly as supplied, review the returned legal entity and location, and compare them with your transaction documents. Registration is not FDA approval; the exact device may still require separate clearance or approval evidence.
Red flags a number check can reveal
The returned location or establishment context conflicts with the supplier's description.
The supplier treats an establishment number as if it proved FDA clearance of the product.
Important: screenshots and supplier-created certificates are supporting documents, not a substitute for checking the official FDA record.
A practical registration-number workflow
- Copy the full number from the supplier document and preserve the original file.
- Run the lookup and record the establishment name, FEI and country returned.
- Resolve any mismatch with the supplier before paying or shipping.
- Confirm the establishment and any device-specific regulatory reference directly with FDA.
Registration number questions
Is an FEI the same as a registration number?
They are related establishment identifiers but may appear as separate fields in public data. Compare the full returned record rather than relying on the label alone.
What should I do when no match appears?
Check every digit, request the exact legal establishment name and confirm the claim directly in the official FDA source. No match by itself is not a final conclusion.