What is UDI?

UDI stands for Unique Device Identification and is a system that tracks medical devices through every phase of their lifecycle:

From Manufacturing through Patient Use

It’s complicated for a reason: More information means improved patient safety, better device tracking, streamlined product surveillance and more.

UDI involves elements such as serial number, lot number, brand name, manufacturing date, expiration date, size, storage information and so much more. Some regions have over 100 elements, and not all are necessary for every product, requiring extensive knowledge to be in compliance.

In addition, many countries have their own, specific UDI regulations, with more countries joining the list often:

  • United States

  • European Union

  • Brazil

  • Taiwan

  • South Korea

  • China

  • Saudi Arabia

  • Singapore