The Basic UDI-DI is a higher-level identifier than the UDI. It groups together several devices that share the same intended use, risk class and basic design and manufacturing characteristics.

This is how it differs from the UDI:

• It does not appear on the label or packaging of the device.
• It is not used for the sale or tracking of individual units.
• It is mandatory in official documentation, e.g. Declarations of Conformity, Technical Documentation and Summary of Safety and Performance Characteristics.
• In EUDAMED, the Basic UDI-DI identifies the device family and is the starting point for consulting all regulatory information concerning it.