Match a legal establishment, location, FEI and role instead of relying on a marketplace brand or supplier-created certificate.
Independent · public-data based · not affiliated with FDA
About FDADeviceCheck.
FDADeviceCheck helps importers, distributors and supplier-quality teams review a medical-device establishment record before they rely on a supplier claim.
Identity
An independent Covo Capital project led by Amaury Covo.
FDADeviceCheck is not part of, affiliated with, sponsored by or endorsed by the U.S. Food and Drug Administration. The FDA name is used only to describe the public agency data and regulatory records the tool helps users review.
Why the tool exists
Separate establishment registration from device listing, classification, clearance, authorization and approval.
Direct users to the official FDA database for the final, time-sensitive verification.
What FDADeviceCheck does—and does not do
The lookup queries the openFDA Device Registrations & Listings endpoint by legal name, FEI or registration number.
Any printable record is informational and is not an FDA document, compliance determination or proof of device approval.
The service is not legal, regulatory, customs or medical advice and cannot determine import admissibility.
Editorial rule: when a public-data field is absent, delayed or ambiguous, FDADeviceCheck treats it as “not confirmed in this result” rather than asserting noncompliance.
How the service is supported
The public lookup is available without charge. FDADeviceCheck may invite users to request a dated record, monitoring pilot or bulk service. Submitting a request does not itself start a payment, monitoring schedule or subscription; any scope, price and activation must be confirmed separately.