Standardized service

Medical Device Listing (Per Device)

After establishment registration, every device marketed in the U.S. must be listed with the FDA, declaring its product code, proprietary name, and premarket submission number. Listing is handled per device, and we complete each filing with you.

RegulatorU.S. FDA

PrerequisiteEstablishment registration completed

UnitPer device

TimelineA few business days per device

On this page

What this service is

Device Listing is the FDA requirement under 21 CFR Part 807 for a registered establishment to declare each device it markets in the U.S., including the proprietary name, product code, regulation number, and the activities performed at the establishment.

All listing information must be submitted electronically unless the FDA grants a waiver. If a device requires premarket review, the corresponding 510(k), De Novo, or PMA number must be provided at listing; 510(k)-exempt devices can be listed directly.

FD&C Act §510(j)21 CFR Part 807 Subpart B

Who needs it

Manufacturers and exporters that have completed establishment registration and need to list specific devices

Registered establishments expanding their product lines with new listings

Companies whose device information (name, model, code) has changed and whose listings need updating

Prerequisites and sequence

FDA Establishment Registration→Device Listing

Establishment registration is completed or filed in parallel (listing attaches to the registration account).
The product code and regulation number for each device are determined, and the 510(k) status is confirmed.
For cleared devices, the 510(k) number and other premarket submission details are ready.

Who holds regulatory responsibility

The listing obligation rests with the owner/operator of the registered establishment. We verify product codes and prepare and submit the listings; you must ensure the listed content matches the devices actually marketed.

Materials we need from you

Proprietary name and model/brand information for each device

Product code and regulation number (we help look them up if not yet determined)

Premarket submission numbers such as 510(k) (if applicable)

Establishment registration number or FEI

Process

01
Verify classification, product code, and 510(k) status for each device
02
Submit listing information device by device in the DRLM system
03
Obtain listing confirmations and verify the public database entries
04
Archive the listing records and explain ongoing update obligations

Deliverables

FDA listing confirmation for each device

Listing verification records

Change and annual update reminders

Timeline

Once registration is complete and codes are confirmed, listing each device typically takes a few business days.

Scope

What we provide

Product code and regulation number verification
Per-device listing submissions
Result verification and archiving
Coordination with annual registration renewal

What is not included

Premarket submissions such as 510(k) themselves (separate engagement)
UDI/GUDID data submissions (a separate service)
Reclassification assessments triggered by major product changes (assessed separately)

What usually follows

UDI Device Submission Device Label Review

Common pitfalls

Filing with an unverified product codeThe product code determines whether a listing is correct; the wrong code invalidates the filing. Verify the code and regulation number in the FDA product classification database against the intended use before submitting.

Treating listing as FDA recognition of the deviceListing is an information filing and does not constitute FDA recognition of safety or effectiveness. Marketing language such as "FDA approved" based on listing is misleading and can raise misbranding issues.

Not updating listings after device changesWhen device names, models, or codes change, the listing must be updated to match what is actually marketed. Listings left unmaintained surface as discrepancies during FDA checks or customer due diligence.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

If our establishment has multiple products, does each one need a listing?

Yes. Listings are filed per device; each device (distinguished by product code and proprietary name) needs its own listing. Where many models or brands are involved, we help structure the listings sensibly.

Can a 510(k)-exempt device be listed?

Yes. Exempt devices do not require a 510(k) and can be listed directly once establishment registration is complete, though labeling, quality system, and other applicable requirements still apply.

What if we are not sure about the product code?

The product code determines whether the listing is correct, so it should be verified before filing. We can search the FDA product classification database based on your device's intended use and technology to confirm the applicable code and regulation number.

Related services

Establishment RegistrationManufacturers, initial importers, specification developers, and other establishments that intend to market medical devices in the U.S. must complete annual establishment registration with the FDA under 21 CFR Part 807 and pay the annual registration fee. We support classification checks, filing, and annual renewal.UDI SubmissionWe help the labeler submit each device's DI data to the FDA GUDID database. This service is scoped per group of up to 5 devices, with additional devices arranged separately — suited to first submissions or smaller portfolios.Device Label ReviewWe review primary and secondary device labels against FDA labeling regulations (21 CFR Part 801 and related rules), flag non-compliances, and recommend corrections — reducing misbranding and port detention risk.

Disclaimer

This is a listing assistance service, not legal advice. Listing does not constitute FDA recognition of a device's safety or effectiveness.