U.S. FDA / device establishment registration & listing

Is your medical device supplier actually FDA registered?

Before you import or wire a deposit, confirm the manufacturer has an active FDA establishment registration, an FEI number and a valid U.S. Agent. An unregistered or misrepresented supplier can mean import detention, a 21 CFR 807 violation and seized shipments at the port. Registration is not the same as 510(k) clearance or FDA approval, and we make that line explicit.

Medical device manufacturing cleanroom with technicians in sterile coveralls

openFDA device registration & listing endpoint

FEI establishment identifier lookup

01Search

Manufacturer name or FEI / registration number.

02Verify

Registration status, US Agent, establishment type.

03Decide

Buy, request documents, or walk away.

Where it saves you

A fast supplier check before you import a medical device.

Importers Confirm the foreign manufacturer is registered and has a US Agent.

Avoid FDA import detention and Import Alert holds for unregistered establishments at the port of entry.

Distributors / buyers Vet a new supplier before placing an order.

See establishment type, registration status and listed proprietary device names in one lookup.

Procurement / hospitals Separate "FDA registered" claims from real FDA clearance.

Catch vendors who imply approval when they only hold an establishment registration.

Registration is not approval

What an FDA registration actually tells you.

RegistrationThe facility is on file with the FDA

21 CFR 807 establishment registration means the maker listed its facility and devices. It is mandatory, but it is not a quality endorsement.

510(k) / PMAClearance and approval are separate

510(k) clearance or PMA approval review a specific device. A registered firm may sell devices that were never cleared or approved.

US AgentRequired for foreign makers

Every foreign establishment must designate a U.S. Agent. A missing agent is a red flag for an incomplete registration.

Source

Public FDA open data.

DatasetopenFDA /device/registrationlisting

The FDA device establishment registration & listing endpoint at api.fda.gov, refreshed from the FDA Unified Registration and Listing System (FURLS).

IdentifierFEI & registration number

The FDA Establishment Identifier (FEI) and registration number that key each facility and its proprietary device names.

UsePre-purchase verification

Look up status before you import or buy. Confirm the final record on the FDA website before any regulatory filing.

FAQ

Common questions about FDA device registration.

Does FDA registration mean the device is FDA approved?

No. Establishment registration only means the facility and its devices are listed with the FDA. It is not 510(k) clearance, PMA approval, or any FDA endorsement, and the FDA prohibits claiming otherwise.

What is an FEI number and how do I search by it?

The FEI (FDA Establishment Identifier) is a 7 to 10 digit number assigned to each facility. Paste it into the lookup, or search by company name, and we match it against the openFDA registration data.

Why does a foreign manufacturer need a US Agent?

Foreign establishments must designate a U.S. Agent for FDA communications. No US Agent on record can mean an incomplete registration and devices detained at the border.

Dossier

Turn the lookup into a supplier dossier for your file.

A dated PDF dossier with the establishment's registration status, FEI number, US Agent and listed device names. We can also connect you to a US Agent / FDA registration partner or run full supplier vetting.

Dossier $14

One supplier: FDA registration status, FEI, US Agent, establishment type and dated PDF.

US Agent / registration Need a US Agent?

We connect you with Registrar Corp to obtain FDA establishment registration or act as your U.S. Agent.

Full vetting $149

Full supplier vetting: registration history, 510(k) cross-check, warning letters and import alerts.