A 7–10 digit input is searched against both the FEI number and establishment registration number fields.
Transparent source and interpretation rules
How FDADeviceCheck builds a lookup result.
The tool summarizes a limited public-data query. It does not reproduce the complete FDA record or make a regulatory, legal, customs or medical determination.
Primary source
openFDA Device Registrations & Listings.
FDADeviceCheck queries the public /device/registrationlisting API. 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.
How a query is constructed
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.
Corrections and review date
This methodology was last reviewed on July 27, 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.