Unique Device Identifier (UDI)


A UDI (Unique Device Identifier) is a code that is unique in the world for identifying medical devices. The code consists of two parts with numeric or alphanumeric characters: a fixed part, the Device Identifier (DI), and a variable part, the Production Identifier (PI). 

GS1 is an accredited UDI-issuing organisation that helps you comply with international regulations, such as EU MDR & IVDR and US FDA, that require suppliers to assign a UDI to their products.


Compliance with UDI regulations

Compliance with UDI requirements for medical devices is based on 3 principles (defined by IMDRF):

  • Identification
  • Scanning
  • Storage in a regulatory database
flow capture identify share

The UDI-DI can be encoded in a GS1-128 or DataMatrix barcode

As a supplier, you are required to register your data (= UDI-DI) in a regulated government database.  

For America (FDA), it is GUDID and you can publish your UDI-DI from My Product Manager.   

For Europe, it is EUDAMED. We are currently looking into publishing the data via My Basic UDI-DI Manager. Send an e-mail to healthcare@gs1belu.org, should you be interested in this. 

Discover My Basic UDI-DI Manager


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