Basic UDI-DI — Basic UDI device identifier

The primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

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Benefit-risk determination