Define
Build the UDI hierarchy and data dictionary with sources and owners.
UDI, GUDID and FURLS
Identifiers, listings and registrations set up correctly
Build a clean plan for UDI assignment, prepare GUDID records that match your label and packaging, and complete FURLS registrations with zero guesswork.
Correct assignment
Device, package and production identifiers mapped
Device, package and production identifiers mapped
Clean records
GUDID fields complete and consistent
GUDID fields complete and consistent
Audit ready
Labeling and data linked for quick checks
Labeling and data linked for quick checks
Market aligned
Path for US now and EU/Canada later
Path for US now and EU/Canada later
Scope
What we execute and what you receive
We structure UDI data, labels and submissions so regulators and auditors see a consistent story across systems.
Registration and UDI activities
- Device and package UDI assignment strategy
- Data dictionary and source mapping for GUDID
- Label and packaging review for UDI and required symbols
- FURLS account and device listing setup and updates
- Change control and production identifier policy
- Supplier and relabeler coordination when applicable
- Cross checks with QMS, tech files and submissions
Deliverables you bring to inspection
- UDI assignment plan with device and package hierarchy
- GUDID data set with validations and screenshots
- Label set with UDI placement and barcode specs
- FURLS registration details and device listings
- Change and production identifier procedures
- Data lineage and source-of-truth mapping
How it works
From data model to live listings step by step
We align activities with your device and systems so each task builds complete data and labels that match reality.
Assemble
Validate GUDID fields, align labels and create FURLS listings with proofs.
Maintain
Manage changes and production identifiers and keep listings up to date.
FAQ
Common questions
Do we need a UDI for every package level?
We confirm levels based on how your product is distributed and used, then assign identifiers accordingly.
Can you integrate with our ERP or label system?
Yes. We map data sources, create a clear owner model and validate outputs against requirements.
What happens when a label changes?
We update the data set, regenerate proofs and maintain GUDID and FURLS listings under change control.
Is this only for US markets?
We focus on US now and align the approach so EU and Canada additions are straightforward later.
Ready to set up UDI and registrations?
Book a quick call to align data, labels and listings so regulators see a consistent picture.