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A Unique Device Identifier (UDI) needs to be included on device packaging and labeling with device attributes being submitted to a new database (GUDID) facilitating device and manufacturer traceability. Following its success, similar initiatives are now rolling out globally, most notably the new EU MDRs. Kallik supports many major medical device manufacturers with their UDI labeling requirements.

How does Kallik help with UDI compliance?

Kallik helps medical device manufacturers ensure their products are correctly labeled in accordance with UDI requirements including human and machine-readable device and production identifiers along with the correct formatting of manufacturing and expiration dates.


• UDI compliant machine and human readable barcodes included as standard


• End-to-end system from artwork creation to factory printing, ensuring labels printed comply with the UDI standard


• Integration with production planning systems such as ERP to ensure traceability and connectivity, as well as auto population of run-time data

Check out our latest Medical Device resources