303-271-0986 info@doranix.com


Unique Device Identification

“FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form.”

The publications below attempt to explain and distill the new UDI requirements and showcase the ThermaPrint64 label printer and applicator as a proven solution to implement the UDI system.

Guidelines for FDA Unique Device Identification Requirements

Label Printing to Meet 2013 FDA UDI Medical Devices Regulations

Quick Reference Guide for FDA Regulatory UDI Requirements

Taking the Stress out of the FDAs UDI Labelling Regulations