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To sell Class I, II, III medical devices or Class A, B, C, D in vitro diagnostic medical devices  in Europe, manufacturers must comply with the EU MDR/IVDR regulation, which includes assigning a Unique Device Identifier, Device Identifier (UDI-DI). This starts with obtaining Global Trade Item Numbers (GTINs) then Basic UDI, typically issued by GS1, a globally recognized issuing entity.

GS1 & GTINs for Class I Medical Devices

EasyUDI simplifies the GTIN registration process by guiding you step-by-step

Already have GTINs? EasyUDI lets you import and manage them with ease.

Understand how to register with GS1

We explain the basics of GS1 registration and help you understand what you’ll need from your local GS1 Member Organization.

Structure and link your GTINs to products

EasyUDI shows you how to use your GTINs correctly and link them to your devices inside our platform for compliance and labeling.

Validate identifiers for EU MDR compliance

We ensure that your GTINs meet EU MDR/IVDR and EUDAMED requirements before moving forward with registration and labeling.

Why GTINs Matter

Required for EUDAMED registration

Ensure global traceability and compliance

Compatible with most ERP, labeling, and regulatory systems

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