The lookup and related content are not legal, regulatory, customs, import, quality-system or medical advice.
Effective September 21, 2026
Terms of use.
These terms describe the informational scope and limitations of the independently operated FDADeviceCheck public-data lookup and request-based services.
Independent service
FDADeviceCheck is not the FDA.
The service is an independent Covo Capital project led by Amaury Covo. It is not part of, affiliated with, sponsored by or endorsed by the U.S. Food and Drug Administration. It does not issue FDA certificates, official records or compliance determinations.
Informational use only
An establishment match does not prove device listing, clearance, authorization, approval, quality, safety or legal marketability.
The service cannot determine whether FDA, Customs or another authority will admit, detain, examine or refuse a shipment.
Public-source limitations
- FDADeviceCheck relies on public openFDA data that can be delayed, incomplete, changed, unavailable or differently structured from the official public database.
- Broad searches may be truncated, grouped or summarized; displayed proprietary names and roles are not necessarily a complete inventory.
- A reported active status reflects the source record and dataset date, not a warranty of current compliance.
- A no-match or absent field is not proof of non-registration, noncompliance or a missing U.S. Agent.
Your responsibility: verify every time-sensitive establishment and device conclusion in the appropriate official FDA source and obtain professional advice when the decision carries regulatory, financial, safety or import consequences.
Requests, pilots and payment
A submitted form is a request for follow-up. It does not by itself create an active monitoring service, subscription, professional engagement or payment obligation. Any paid or recurring service requires separate confirmation of scope, price, activation and fulfillment terms. Do not assume service has started until FDADeviceCheck confirms it through a project-domain communication.
The paid automated cross-check
Where offered, the automated FDA supplier cross-check is a one-time purchase of US$10 per supplier name. It is generated automatically after payment from public FDA sources and emailed as a PDF to the address given at checkout, normally within minutes; source or email outages can delay delivery. One payment covers one supplier query, not a batch, subscription or monitoring. Previous purchases retain the price paid and the same delivery. It is not human-reviewed, not an FDA certificate and not proof that a firm is unregistered; the report itself lists the FDA records that have no public API and were not checked. If the report does not arrive, cannot be opened or was generated for the wrong name, reply to the delivery email or the receipt within 14 days and the check will be re-run or the purchase refunded in full.
Seller of record and payments. Paid checks are sold and delivered by Covo Franco Digital LLC, 30 N Gould St Ste N, Sheridan, WY 82801, United States, which appears on your card statement and receipt. Card payments are processed by Stripe under Stripe's own terms; FDADeviceCheck never receives your card details. The free lookup and the free dated record remain provided by the operator named on the About page.
Acceptable use
Do not use it to misrepresent FDA status, create a false certificate, impersonate another party or support unlawful sales or imports.
Do not bypass technical limits, overload the service, probe for secrets or interfere with other users or source systems.
Official FDA and third-party sites linked from FDADeviceCheck have their own terms, notices and access controls.
Availability and changes
The service may be corrected, limited, suspended or changed without guaranteeing continuous availability. Content and methodology may also change when FDA sources or regulations change. The effective date above identifies the current published version of these terms.