UDI-DI vs UDI-PI vs Basic UDI-DI: A Practical Label Guide

UDI-DI identifies the device version or model, UDI-PI describes applicable production information, and the EU Basic UDI-DI groups related devices for regulatory purposes. They are related identifiers with different roles. Keeping them separate prevents a regulatory grouping reference from being entered as a product barcode value.

Identify the model, then the production

The UDI-DI is the device identifier. The UDI-PI is production information such as lot, serial, and relevant dates, depending on what applies to the device. Two units of one model may share a DI but have different production data.

The Basic UDI-DI is an EU regulatory identifier used in documentation and database relationships. It is not the UDI carrier value placed on the device label. It should not be substituted for the labelled UDI-DI.

Map a GS1 example

For a demonstration label, imagine these controlled fields:

• Model reference: DEMO-DEVICE-A.
• GTIN: 09506000134352, used here only as sample data.
• Lot: DEMOLOT7.
• Expiration date: 31 December 2027.
• Serial: DEMO0001.

In a GS1 workflow, the GTIN under AI (01) represents the DI. Lot (10), expiry (17), and serial (21) carry the corresponding production attributes. The readable example is:

(01)09506000134352(17)271231(10)DEMOLOT7(21)DEMO0001

This example illustrates field placement, not which production attributes every device must carry. Other issuing systems use their own structures; not every UDI is a GS1 string.

Separate the artwork checks from record checks

Keep one review sheet with the approved model reference, assigned DI, applicable production fields, and the relevant database reference. Compare the sheet with the barcode result and the readable label text independently.

If DEMO0001 changes to DEMO0002, review the serial in both places. If the packaging configuration changes, determine the appropriate identifier from the controlled assignment process rather than simply editing the number. A correct check digit does not prove the identifier belongs to that model.

Build the label in UDImaker

1. Open the UDI label designer.
2. Replace the demonstration GTIN and enter the applicable production fields.
3. Place readable product information and the barcode without obstructing the quiet zone.
4. Decode the exported image and compare its fields with your review sheet.
5. Print and inspect the production sample separately.

UDImaker prepares GS1-based artwork; it does not issue a Basic UDI-DI, allocate device identifiers, or submit GUDID or EUDAMED records. Continue with the UDI validation guide for the distinction between data checks, record consistency, and physical symbol quality.