Standardized service

UDI Device Submission to GUDID (Up to 5 Devices)

We 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.

DatabaseFDA GUDID

PrerequisitesGUDID account and DI codes

ScopeUp to 5 devices per group

TimelineAbout 1-2 weeks

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What this service is

The UDI (Unique Device Identification) is a unique identifier generated under an internationally recognized issuing standard, composed of a Device Identifier (DI) and a Production Identifier (PI). The DI identifies the device model and must be submitted to GUDID as public data.

The UDI carrier (automatic identification formats such as barcodes, plus human-readable form) must appear on the device label and every level of packaging; reusable devices also require direct marking on the device itself. Data submitted to GUDID must stay consistent with labeling and registration/listing information.

FD&C Act §519(f)21 CFR Part 83021 CFR 801.20

Who needs it

Labelers whose GUDID account is active and who need to submit device DI data

Manufacturers and specification developers submitting a first batch of no more than 5 devices

Companies with existing GUDID records that need updates due to label or model changes

Prerequisites and sequence

Device Listing→GUDID Account Creation→UDI Device Submission

The GUDID account is active (account creation assistance is available first if needed).
Each device has a DI code from an issuing agency (GS1/HIBCC/ICCBBA).
FDA device listing is completed or handled in parallel; UDI data must match the listing.
Devices are scoped in groups of up to 5; devices beyond the first 5 are arranged separately per additional device.

Who holds regulatory responsibility

The labeler is responsible for GUDID submissions and must keep the data accurate and up to date. We organize the submission data, perform the filings, and verify results; you provide authentic product and code information.

Materials we need from you

DI code and issuing agency information for each device

Proprietary name, model, and specification description of each device

Device labeling (showing the UDI carrier)

FDA listing number and the corresponding product code

GUDID-required attributes such as sterility, single-use status, and MRI safety (as applicable per device)

Process

01
Organize the DI codes and attribute data for each device
02
Check required GUDID data elements against labeling and listing information for consistency
03
Submit the device records in GUDID one by one
04
Verify the public database entries and correct them if needed
05
Archive the submission records and explain ongoing update obligations

Deliverables

GUDID submission confirmation for up to 5 devices

Archived submission data for each device

Guidance on update obligations (records must be updated promptly when information changes)

Timeline

With complete data and codes in place, submission and verification typically take about 1-2 weeks.

Scope

What we provide

Submission data preparation and completeness check
GUDID submissions for up to 5 devices
Result verification and correction
Guidance on ongoing update obligations

What is not included

UDI code fees (charged by the issuing agencies)
Submissions for devices beyond the first 5 (arranged separately)
Design and printing of the UDI carrier on labels

What usually follows

Device Label Review IFU Review

Common pitfalls

UDI data inconsistent with listing and labelingData submitted to GUDID must match the FDA listing and the device labeling. Contradictions across the three are flagged during FDA checks or purchaser audits, so reconcile them before filing.

Reporting PI data such as lot numbers into GUDIDGUDID only takes Device Identifier (DI) data; the Production Identifier (PI) is out of scope. Mixing the two produces incorrect submissions and adds unnecessary maintenance burden.

Not updating records after changes, or missing new-DI triggersGUDID records must be updated promptly when information changes; if a change affects intended use or model specifications, a new DI may be required instead of editing the old record. Delayed updates leave public data out of sync with the physical product.

Overlooking direct marking on reusable devicesReusable devices require the UDI directly marked on the device itself, in addition to labels and packaging. Covering only the packaging is a common compliance gap.

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.

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FAQ

What if we have more than 5 devices?

This service covers groups of up to 5 devices; additional devices are arranged per device. For larger portfolios, bulk (XML) submission can be evaluated — we can explain the options in consultation.

Does standalone software need a UDI?

Yes. Commercially distributed standalone medical software (SaMD) must also be assigned a UDI and submitted. Software version identification can serve as the production control mechanism within the UDI-PI.

Do we resubmit when product information changes?

GUDID records must be updated promptly after information changes. If a change affects the intended use or model specifications, a new DI may be required. We explain the specific change-trigger rules.

Related services

GUDID AccountGUDID 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.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.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 data submission assistance service. GUDID data is public; the labeler is ultimately responsible for the accuracy and timely updating of submitted data.