UDI
Unique Device Identifier: A standard code that identifies a specific device model and the batch it came from.
A Unique Device Identifier comes in two parts: a Primary DI covering the device model and labeler, and a production identifier carrying lot or serial details. Together they let regulators follow devices through distribution and tie Recall notices and Adverse Event reports to the right products. The US and EU both require UDIs on device labels, linking records through keys such as the Basic UDI-DI.