Avoid FDA import detention and Import Alert holds for unregistered establishments at the port of entry.
U.S. FDA ยท device establishment registration & listing
FEI number lookup:
is your device supplier FDA registered?
Search the openFDA establishment registry by manufacturer name or FEI number before you import or wire a deposit. Confirm the registration is active, the FEI is real, and a U.S. Agent is on record — in seconds.
Informational lookup of public FDA establishment data. Registration is not 510(k) clearance or FDA approval. Verify the record directly with the FDA before importing.
- openFDAregistration & listing endpoint
- FEIestablishment identifier lookup
- 21 CFR 807establishment registration basis
The deliverable
A dated, file-ready supplier dossier.
Every lookup can be turned into a PDF dossier — registration status, FEI number, U.S. Agent and listed device names, stamped with a folio code for your import file.
Not an FDA approval, clearance, or endorsement. We do not issue official documents.
Registration is not approval
What an FDA registration actually tells you.
What registration DOES mean
- The facility is on file with the FDA. 21 CFR 807 establishment registration means the maker listed its facility and devices. It is mandatory.
- It has an FEI & registration number. A unique identifier keying the facility and its proprietary device names.
- Foreign makers named a U.S. Agent. Every foreign establishment must designate one for FDA communications.
What it does NOT mean
- It is not a quality endorsement. Registration is not the FDA approving, clearing or vouching for any product.
- It is not 510(k) or PMA. Clearance and approval review a specific device. A registered firm may sell devices that were never cleared.
- A missing U.S. Agent is a red flag. An incomplete registration can mean devices detained at the border.
Where it saves you
A fast supplier check before you import a medical device.
See establishment type, registration status and listed proprietary device names in one lookup.
Catch vendors who imply approval when they only hold an establishment registration.
Source
Built on public FDA open data.
The FDA device establishment registration & listing endpoint at api.fda.gov, refreshed from the FDA Unified Registration and Listing System (FURLS).
The FDA Establishment Identifier (FEI) and registration number that key each facility and its proprietary device names.
Look up status before you import or buy. Confirm the final record on the FDA website before any regulatory filing.
Dossier
Turn the lookup into a supplier dossier for your file.
A dated PDF dossier with the establishment's registration status, FEI number, US Agent and listed device names. We can also connect you to a US Agent / FDA registration partner or run full supplier vetting.
One supplier: FDA registration status, FEI, US Agent, establishment type and dated PDF.
We connect you with Registrar Corp to obtain FDA establishment registration or act as your U.S. Agent.
Full supplier vetting: registration history, 510(k) cross-check, warning letters and import alerts.
FAQ
Common questions about FDA device registration.
Does FDA registration mean the device is FDA approved?
No. Establishment registration only means the facility and its devices are listed with the FDA. It is not 510(k) clearance, PMA approval, or any FDA endorsement, and the FDA prohibits claiming otherwise.
What is an FEI number and how do I search by it?
The FEI (FDA Establishment Identifier) is a 7 to 10 digit number assigned to each facility. Paste it into the lookup, or search by company name, and we match it against the openFDA registration data.
Why does a foreign manufacturer need a US Agent?
Foreign establishments must designate a U.S. Agent for FDA communications. No US Agent on record can mean an incomplete registration and devices detained at the border.