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
Frequently Asked Questions
Unique Device Identification — a device identifier plus production identifiers for medical-device traceability.
The device identifier (DI) names the model; the full UDI adds production identifiers such as lot, serial, and expiry.
Any of GS1, HIBCC, or ICCBBA; the choice depends on the market and product type, and the syntax must match.