What is a UDI Barcode?

Unique Device Identification (UDI) is a worldwide system to uniform product labelling for medical goods. UDI serves as a key to a UDI database (Unique Device Identification Database; UDID), which contains a number of product information. The products and packaging receive a UDI data carrier which contains the identification number. For the UDI carrier the barcode types Code 128 and Data Matrix (ISO/IEC 16022) are used.

EU UDI Requirements

All medical goods and in-vitro diagnostics must be clearly identifiable worldwide.

UDI Device Identifier (UDI-DI)

The UDI-DI is a unique numeric or alphanumeric code which identifies the article (static data). Within the GS1 system, the GTIN (Global Trade Item Number) is used for the UDI-DI.

UDI Production Identifier (UDI-PI)

The UDI-PI enables traceability with data such as batch, expiration date, serial number (dynamic data). Within the GS1 system, the corresponding GS1 Application Identifiers are used.

Basic UDI-DI

The basic UDI-DI is the primary identifier of a product type, which is assigned at the level of the usage unit of the product. It is the most important classification characteristic for data records in the UDI database and is shown in the EU declarations of conformity. The Global Model Number (GMN) can be used in the GS1 system to implement the basic UDI-DI.