Unique Device Identifier

A code that identifies a specific device through its distribution and use. The US and the EU define the term; Canada's Medical Devices Regulations do not use it.

Where it is written

21 CFR 830.3; Regulation (EU) 2017/745, Article 2(15); Medical Devices Regulations (SOR/98-282), full text searched for the term, none found (1 November 2026)

Also called

UDI

Regimes

• Unique Device Identifier (US)A code that identifies a device through its distribution and use. The device identifier is fixed and identifies the version or model and the labeler. The production identifier varies and can show the lot, serial number, expiration date, or manufacture date.
• Unique Device Identifier (EU)A series of numeric or alphanumeric characters, created through internationally accepted device identification and coding standards, that allows unambiguous identification of specific devices on the market. Under the EU MDR the UDI has two parts, a device identifier and a production identifier.

Related terms