Unique Device Identification (UDI)

What is a Unique Device Identifier?

A UDI is a numeric or alphanumeric code used to identify a medical device. The FDA UDI system and the EU system both use UDI to improve device identification and traceability, but their data and implementation rules are not identical.

UDI supplements other labeling and registration requirements. Assigning an identifier does not by itself authorize a device for sale.

What is the difference between UDI-DI and UDI-PI?

The Device Identifier, or UDI-DI, is the fixed portion identifying the labeler or manufacturer and a specific device version or model. The Production Identifier, or UDI-PI, is the variable portion containing applicable production information such as a lot, serial number, expiration date or manufacturing date.

Which production fields must appear depends on the device, its labeling and jurisdictional rules.

What is a Basic UDI-DI?

Basic UDI-DI is an EU concept used to connect a group of devices with the same intended purpose, risk class and essential design and manufacturing characteristics. It appears in regulatory documentation and EUDAMED but is not the identifier placed on the product label.

Basic UDI-DI should not be confused with UDI-DI, FDA DI or a catalogue number.

Does assigning a UDI register the device?

No. A manufacturer typically obtains identifiers through a recognized issuing agency, applies the required UDI carrier and submits specified data to the relevant database.

In the United States, device labelers submit data to GUDID. In the EU, manufacturers submit UDI/device data to EUDAMED. As of July 2026, the first mandatory EUDAMED modules, including UDI/Device registration, have applied since May 28, 2026. See EUDAMED.

Is there one global UDI system?

No. International guidance promotes convergence, but databases, data fields, deadlines, exceptions and direct-marking rules remain market-specific. Manufacturers should build a global identifier strategy while validating requirements for each jurisdiction.

Pure Global provides regulatory context for the United States, European Union and Brazil. For Brazil-specific developments, see the ANVISA UDI database update.