V5 Ultimate
Inventory & traceability

UDI-DI vs UDI-PI

device identifier · production identifier

TL;DR

The two halves of a Unique Device Identifier: UDI-DI identifies the device model; UDI-PI identifies the specific production batch/serial/expiry.

A UDI has two parts. The UDI-DI (Device Identifier) is a static code identifying the device model, manufacturer, and packaging level — used as the access key in GUDID/EUDAMED. The UDI-PI (Production Identifier) is variable and encodes lot/batch number, serial number, manufacturing date, or expiry. Together they enable per-unit traceability for recalls and PMS.

V5 enforces UDI-DI assignment at design release and prints the correct DI+PI combination at every packaging level, validated against the registered GUDID/EUDAMED record.

Regulatory anchors
  • 21 CFR 830
  • EU MDR Art. 27
  • IMDRF UDI Guidance
Industries that live with this
Medical Devices
How V5 handles it
eBMR / eDHR — the batch record writes itself.
When the master is locked and the operator works on the kiosk, the batch record is no longer something to assemble — it’s something to render.
21 CFR Part 11 — the operating model, not a checkbox.
Other systems bolt Part 11 on top. V5 enforces it at the database layer so application code can never rewrite history.
Related terms
UDIDHReDHREU MDRIVDR
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