Unique Device Identification (UDI)
What is Unique Device Identification (UDI)
A Unique Device Identification (UDI) system is intended to provide single, globally harmonized positive identification of medical devices through distribution and use, requiring the label of devices. Various international legislation (U.S. FDA and MDR) require medical tools suppliers to add a Unique Device Identifier (UDI) to their products. Being an accredited party, we can assist you with GS1 barcodes.
How to compose an UDI?
- Assign a unique identification (Global Trade Item Number - GTIN).
- Additionally, depending on legislation demands add a batch/lot number, expiration date and/or a serial number, using Application Identifiers.
- Assign the UDI on products in both text and symbol. You may use a GS1 DataMatrix or a GS1-128.
- Also create the Global Model Number, GMN supports the implementation of the Basic UDI-DI to identify a product model or product family.