Unique Device Identification (UDI) is an essential part of a medical device's lifecycle. It is aimed at patient safety, product traceability and post-market surveillance. The assignment of a unique identifier to each medical device, including manufacturing information and expiration date, is recorded and accessible.

Several international regulatory bodies have enacted UDI requirements, including the US FDA and European Union. However, each country with the requirement has its own system (GUDID, EUDAMED) and it is crucial for global medical device manufacturers to address each country's specific requirements.

One Realm can help you understand specific UDI requirements, terms and databases for each country.