US FDA GS1 UDI Declaration Form

Declaration to U.S. FDA regarding the use of GS1 barcode numbers (GTINs) to identify Medical Devices.

If you manufacture or distribute any product that is exported to the United States and that is classified as a “medical device” you are now required to declare to the FDA if you use your GS1 prefix to “unique device identifiers” or UDIs.

View the Unique Identification of Medical Devices (UDI) Agreed Terms

Team-Photo

New Case Study! Scan4Safety at Tallaght University Hospital (TUH)

Giving time back to patient care

The initiative provides traceability of items used during surgery and procedures, improving the standard of care provided to patients and the Hospital's efficiency.

Read the case study

Healthcare Newsletter Subscribe

Subscribe for Updates

GS1 Ireland Healthcare updates are sent approximately every 6 - 8 weeks. You can opt-out at any time.

Subscribe

UDI-Banner

Are you implementing UDI?

Would you benefit from training or advice on using GS1 Standards in preparation for UDI compliance?

Find out how we can help