Compare a foreign manufacturer's identity and U.S. Agent.
Spot registration or listing mismatches that can delay FDA entry review, then confirm the current official record before shipment.
Independent tool · not affiliated with FDA
FEI number lookup:
is your device supplier FDA registered?
Search by legal name, FEI or registration number. Compare the facility, country, role and U.S. Agent in the latest available openFDA snapshot, then confirm the record in FDA's official database.
Establishment registration only. This does not verify device clearance, approval, authorization, quality or import admissibility. Verify in FDA's official database.
- openFDAlatest available public snapshot
- FEIfacility identity comparison
- Transparentsource date and limits shown
The free record
A dated lookup record, not an FDA certificate.
Generate a server-revalidated PDF with the query, matched establishment, FEI, registration number, roles, U.S. Agent, source date, records inspected and explicit data limitations.
The server checks the public source again when it generates the record. No payment or subscription starts.
Registration is not approval
What an FDA registration actually tells you.
What registration DOES mean
- The establishment reported information to FDA. Establishments subject to the applicable rules generally register annually; most also list their devices.
- The record can help match facility identity. Compare legal name, address, FEI, registration number and roles with the supplier's documents.
- Foreign establishments generally designate a U.S. Agent. The agent serves as a contact for FDA communications under the applicable registration rules.
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), De Novo or PMA evidence. Device-level authorization and any applicable exemption must be checked separately.
- A field not shown is not proof of absence. Treat the U.S. Agent or listing detail as not confirmed by this result and verify in FDA's official source.
Where it saves you
A fast supplier check before you import a medical device.
Vet a supplier before placing an order.
See establishment type, registration status and listed proprietary device names in one lookup.
Separate “FDA registered” from device authorization.
Use the establishment match as one evidence item, then check the relevant device-level pathway and applicable exemptions.
Source
Built on public FDA open data.
openFDA registration & listing
The latest available public snapshot from FDA's registration and listing data. It is not represented as real-time.
FDA Registration & Listing database
Use FDA's own search for the final current check. FDADeviceCheck discloses source date, inspected records and truncation.
Read the methodology
See query logic, status-code interpretation, known data limits, report contents and the distinction from FDA certificates.
Dossier
One free record. Optional pilots by request.
Download a dated PDF at no charge. Monitoring and bulk access are invitation-only pilots; a request never starts service, payment or a subscription.
Dated lookup record
FreeOne server-checked PDF with identity, status, FEI, source date, inspected-record count and limitations.
Start free lookupWatchlist pilot
$19/moProposed price, not an active service. Up to 25 distinct establishments (one FEI per facility), with an initial record and one comparison 30 days later. No automatic renewal.
See a fictional monthly comparison
Illustration only — invented supplier and data. This is an editorial example, not an FDA result or a delivered customer report.
- Example establishment
- Fictional Supplier A — one facility
- First source snapshot (example)
- 3 Aug 2026: U.S. Agent field says “Example Agent A”.
- Next source snapshot (example)
- 1 Sep 2026: U.S. Agent field says “Example Agent B”.
- What the comparison would say
- The field differs between these snapshots. Confirm the current record with FDA; this does not establish when the change occurred or whether a device is approved.
A proposed report would include both source dates, the retrieval date, source links and any incomplete results. If the source snapshot has not advanced, we would say so — not call it a fresh check with no changes. No-match or unavailable data would require review, not be reported as deregistration.
Read the openFDA source documentation. Its published update frequency is monthly; this proposal is not real-time monitoring.
Request only. Tell us how many facilities you need to compare and what recurring task it would help with. An operator, delivery dates and the final scope must be confirmed in writing before any charge. Registration or listing is not FDA approval.
Bulk-file pilot
$49/moProposed file review for up to 250 facilities. API access is scoped separately and is not currently self-serve.
Lookup guides
Start with the identifier or claim you have.
Each guide explains what the public establishment data can confirm, what it cannot confirm, and the next check to make before importing.
FAQ
Common questions about FDA device registration.
Does FDA registration mean the device is FDA approved?
No. Establishment registration and device listing do not mean FDA approval, clearance, authorization, certification or endorsement. Check a device-level 510(k), De Novo, PMA or applicable exemption separately.
What is an FEI number and how do I search by it?
The FEI, or FDA Establishment Identifier, identifies a facility in FDA systems. Enter the 7 to 10 digit number here, or search by legal company name, then compare the returned identity and address with the supplier's documents.
What if a U.S. Agent is not shown in this result?
Treat the U.S. Agent as not confirmed by this result, not necessarily missing. Foreign establishments subject to registration generally designate a U.S. Agent, but you should confirm the current record in FDA's official Registration and Listing database.