When the device registry returns nothing, the lookup also asks the public openFDA drug-label, 510(k) and device and drug recall datasets whether the name appears, and reports the name exactly as that dataset returns it. A hit there is a name match in a different dataset, not a device establishment registration.
Transparent source and interpretation rules
FDA FEI database: where to search and verify a match.
Looking for the FDA FEI database for a medical device supplier? Use FDA's official Registration & Listing search to verify the facility. FDADeviceCheck offers a separate lookup of public FDA data; this page explains its sources, dates and coverage limits. A facility match is not device approval. It does not reproduce the complete FDA record or make a regulatory, legal, customs or medical determination.
Primary source
What an FDA FEI database lookup can show.
FDADeviceCheck queries the public /device/registrationlisting API by FEI, registration number or establishment name. openFDA documents a monthly update cadence and returns a dataset date with successful results. FDA's separate public Registration & Listing database is generally updated weekly and is the final public source we recommend checking.
Choose the source, then check the facility.
- Start with the device establishment record. Search by FEI, registration number or legal establishment name in the FDADeviceCheck lookup, then repeat the check in FDA's official Registration & Listing database.
- Compare identity, not just the number. Check the returned legal name, location and establishment roles against the supplier's documents. A matching FEI does not prove that a seller represents that facility.
- Check the date and coverage. The openFDA device registration API is updated monthly. Read the source date shown with the result; broad searches can exceed this tool's record limits, and no match does not establish that a facility is unregistered.
For a drug establishment, review the separate DECRS source described below. A drug registration is not a device establishment registration.
After a no-match: other public FDA sources
FDA publishes its Drug Establishments Current Registration Site (DECRS) as a daily file without an API. The lookup consults a copy of that file, dated on the result, by FEI or by firm name. A drug establishment registration shares the FEI numbering but is not a device establishment registration and is not an approval; contact details in the file are never shown.
Import alerts, import refusals, inspection classifications (FDA Data Dashboard), warning letters and food facility registrations have no public API or are not published, so a no-match here says nothing about them. They can only be checked by hand.
How a query is constructed
A 7–10 digit input is searched against both the FEI number and establishment registration number fields.
A text input is tried first as an exact establishment name. When at least two meaningful tokens remain after removing common legal suffixes, a no-match can trigger a relaxed all-token search. Broad one-token names never use that fallback.
The lookup accepts ISO two-letter codes or recognized English country names and can apply one supported establishment role as an exact source filter.
No silent filter fallback: an unrecognized country or establishment role produces a validation error instead of running an unfiltered query. Still compare every returned country and role with the supplier documents.
How results are summarized
- The API request inspects up to 100 matching registration-and-listing records returned by openFDA.
- Records are grouped by FEI, registration number and establishment name, then limited to the first 10 grouped facilities.
- The interface labels openFDA status codes 1 and 5 as active, following the official openFDA field reference; other codes are shown for review rather than treated as active.
- The interface shows up to four returned roles and four returned proprietary names per facility. The API/PDF caps each facility at 12 roles, 20 proprietary names and 20 product codes and explicitly marks the response partial if any cap is reached.
Truncation matters: broad name searches can return more source records than the tool inspects. Use a legal name, FEI or registration number, and open the official FDA database when completeness matters.
Interpretation rules
It means the openFDA record carries an active status code on the displayed dataset date. It is not a warranty of current compliance.
Spelling, identifier type, source timing, record limits or a mismatch between seller and facility can all produce no match.
If a U.S. Agent or another field is not present in the inspected result, FDADeviceCheck does not conclude that the underlying registration is incomplete.
What the lookup cannot determine
Establishment registration does not prove 510(k) clearance, De Novo authorization, PMA approval or an exemption for a particular model.
FDA entry review can involve listing, product codes, premarket submissions, labeling, import alerts and other requirements beyond this lookup.
A matching facility record does not prove that a seller is authorized to represent, distribute or manufacture the specific device.
Official verification workflow
- Match the legal entity, location, FEI, registration number and establishment roles to the supplier documents.
- Open FDA Registration & Listing and repeat the search in the official public database.
- Identify the exact device name, model, product code and listing context.
- Use the relevant FDA 510(k), De Novo, PMA, classification, UDI or recall database for device-level evidence.
FDA FEI database questions
Is there one FDA FEI database for every facility?
No. This lookup combines the public openFDA device registration and listing data with a dated DECRS file for drug establishments after a device-registry miss. Import alerts, inspections, warning letters and food facility registrations are outside these sources.
Can I verify an FEI number in the official FDA database?
Yes. Use the official FDA Registration & Listing search to repeat a device-establishment check and compare the legal name, location, FEI, registration number and roles with the supplier documents.
Corrections and review date
The source facts were last reviewed on September 21, 2026; the source-selection guide and openFDA monthly update reference were reviewed October 17, 2026. If you find a mismatch between this explanation and the current lookup behavior or official source, use the contact route and include the page, query type, source date and expected correction. Do not send confidential supplier or patient information.