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UDI – Unique Device Identifier

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A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market. 

Whereas medical device nomenclature helps us to identify the type of medical device, the UDI is unique to the medical device itself, enabling us to identify the medical device and who manufactured it or placed it on the market. 

UDIs consist of: 

  1. a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a model of medical device
  2. a UDI production identifier (‘UDI-PI’) that identifies the unit of medical device production and, if applicable, the packaged medical devices. The different types of UDI-PIs include serial number, lot number, software identification and, manufacturing date or expiry date or both.

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