For Class 1 devices — yes. Pursuant to the rule, Class 1 devices marked with a U.P.C. barcode on the
label are considered to have met the UDI labeling requirements. (The U.P.C. number will serve as the UDI
– which must still be registered in the GUDID with the required data attributes.) For other classes, it will
depend on whether the device contains additional PI(s) on the label or package. Consult with your
regulatory compliance team for additional information and guidance.
