Standardized service

GUDID Account Creation Assistance

GUDID is the FDA-administered database for unique device identification and the entry point for UDI data submissions. We help the labeler apply for a GUDID account and configure the basics, paving the way for UDI submissions.

DatabaseFDA GUDID

Account HolderDevice labeler

ActivationAbout 1-2 weeks

VisibilityPublicly searchable

On this page

What this service is

GUDID (Global Unique Device Identification Database) is an online database operated by the FDA that stores key identification information for devices marketed in the U.S., including device name, model, manufacturer, and the Device Identifier (DI).

Only the DI portion of the UDI is submitted to GUDID; the Production Identifier (PI), such as lot number or expiration date, is not included in the database. Before submitting data to GUDID, the labeler must first establish a GUDID account.

FD&C Act §519(f)21 CFR Part 830 Subpart E

Who needs it

Device labelers implementing UDI compliance for the first time without a GUDID account

Manufacturers and specification developers planning U.S. sales who need to prepare the UDI submission path

Companies that already hold UDI codes but lack access to the database

Prerequisites and sequence

The entity acting as the labeler and its contact details are identified.
UDI codes have been obtained, or are being obtained, from an FDA-accredited issuing agency (GS1, HIBCC, or ICCBBA). Account creation itself does not depend on the codes, but later submissions do.
FDA establishment registration and device listing should be completed or handled in parallel.

Who holds regulatory responsibility

The device labeler is responsible for UDI compliance and GUDID data submissions. We assist with account creation and configuration guidance; the labeler is responsible for the accuracy of the data submitted afterward.

Materials we need from you

Labeler company name in Chinese and English, and address

GUDID account administrator and contact details (name, email, phone)

Company identification information such as the D-U-N-S Number (if requested by the system)

Summary list of devices to be submitted

Process

01
Confirm the labeler entity and account roles
02
Prepare the company and contact information required for the account application
03
Submit the GUDID account request to the FDA and follow up on activation
04
Verify the basic account information once activated
05
Explain the operating path for subsequent UDI data submissions

Deliverables

A working GUDID account

Account information and permission configuration record

Guidance for the UDI submission step

Timeline

Account application and activation typically take about 1-2 weeks, depending on FDA review progress.

Scope

What we provide

Application information preparation and submission
Activation follow-up
Basic account configuration verification
UDI submission process guidance

What is not included

Obtaining the UDI codes themselves (handled with issuing agencies such as GS1/HIBCC/ICCBBA, each with its own fee structure)
GUDID data submissions for specific devices (the UDI device submission service)
Ongoing data maintenance (available as a separate engagement)

What usually follows

UDI Device Submission Device Label Review

Common pitfalls

Submitting PI data (lot number, expiry) into GUDIDGUDID only accepts the Device Identifier (DI) portion of the UDI; the Production Identifier (PI), such as lot number or expiration date, is not part of the database. Scoping PI into the submission wastes effort and invites data errors.

Assuming a GUDID account means you have UDI codesThe GUDID account is only the submission entry point. UDI codes must be obtained separately from an FDA-accredited issuing agency (GS1, HIBCC, or ICCBBA); without codes, an activated account still cannot be used for submissions.

Underestimating that GUDID data is publicDevice identification data in GUDID is publicly searchable by healthcare providers, purchasers, and regulators. Inaccurate or stale submissions are directly visible to customers and authorities.

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

Who assigns the UDI codes?

The FDA has accredited three issuing agencies: GS1, HIBCC, and ICCBBA. You obtain UDI codes from any of them, each with its own fee structure. The GUDID account is for data submission — a separate step from code issuance.

Is GUDID information public?

Yes. Device identification data in GUDID is publicly searchable, allowing healthcare providers, purchasers, and regulators to verify device identity — which is why submission accuracy matters.

Do all devices need a UDI?

The vast majority of devices marketed in the U.S. (including IVDs) must bear a UDI on the label and submit DI data to GUDID. Limited exceptions exist, such as certain cGMP-exempt Class I devices. Confirm by device classification.

Related services

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 ListingAfter 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.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.

Disclaimer

This is an account creation assistance service; account activation is decided by the FDA. UDI code fees are charged by the issuing agencies and are separate from this service.