Glossary · Standards
UDI
Unique Device Identifier
A UDI is the code that identifies a medical device on its label and packaging, made of a device identifier (UDI-DI) for the model and a production identifier (UDI-PI) for the lot, serial number or dates.
The EU MDR and IVDR and the US FDA require it, codes are issued by accredited bodies such as GS1, and device data is registered in EUDAMED in the EU.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →