---
title: What Is a UDI? GS1, HIBCC & ICCBBA
description: A Unique Device Identification (UDI) is a device identifier plus production identifiers, issued in GS1, HIBCC, or ICCBBA syntax for FDA and EU MDR traceability.
canonical: https://stanzaapi.com/guides/udi-explained
---

[Home](/)/[Guides](/guides)/What Is a UDI? Device Identifiers Across GS1, HIBCC, and ICCBBA

# What Is a UDI? Device Identifiers Across GS1, HIBCC, and ICCBBA

A Unique Device Identifier is a device identifier (the model) plus production identifiers (lot, serial, expiry), carried in one of three issuing-agency syntaxes: GS1, HIBCC, or ICCBBA.

Updated 2026-10-01 · 5 min read

## What a UDI is

A Unique Device Identifier identifies a medical device for traceability. It has two parts: a device identifier that names the model, and production identifiers that name the specific unit or batch.

The FDA and the EU MDR require UDI on device labels and, in the EU, in the EUDAMED database.

## Three issuing agencies, three syntaxes

A UDI is carried in one of three syntaxes, chosen by the manufacturer.

- GS1 — the most common, using Application Identifiers such as 01 (device identifier), 17 (expiry), 10 (lot), and 21 (serial).
- HIBCC — a healthcare-industry syntax with its own primary and secondary identifiers.
- ICCBBA — used for blood, tissue, and cellular products.

## The production identifiers

The lot number, serial number, and expiry date are the production identifiers. Together with the device identifier they let a device be traced to a batch or a single unit.

## Why syntax matters

Because the three agencies use different encodings, a decoder must know which one it is reading before it can split the string. Parsing a HIBCC code with a GS1 parser produces wrong fields rather than an error.

## Try it on real data

[Medical Device UDI Barcode & AIDC Engine → — Instant <2ms GS1-128, 2D DataMatrix, HIBCC Modulo-43 & ICCBBA medical device UDI barcode decoder for FDA 21 CFR 801 & EU MDR compliance — Open the tool](/tools/udi-decoder/)

## Frequently Asked Questions

What does UDI stand for?

Unique Device Identification — a device identifier plus production identifiers for medical-device traceability.

What is the difference between a DI and a UDI?

The device identifier (DI) names the model; the full UDI adds production identifiers such as lot, serial, and expiry.

Which issuing agency should a manufacturer use?

Any of GS1, HIBCC, or ICCBBA; the choice depends on the market and product type, and the syntax must match.

## Primary sources

- [FDA — Unique Device Identification System](https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system)
- [GS1 — UDI](https://www.gs1.org/industries/healthcare/udi)