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An Overview of European Unique Device Identification System

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UDI-DI = Device IdentifierUDI-PI = Production Identifier
Unique numeric alphanumeric code specifies to a model of device i.e. GTIN.Numeric alphanumeric code that identifies the unit of device production (=batch identifier) and, if applicable, the packaged devices.
Used as the ‘access key’ to information stored in a UDI databaseDifferent types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date. Serial number mandatory for active implantable devices.
Must be referenced in Declaration of Conformity