Unique Device Identification definition
Examples of Unique Device Identification in a sentence
For details of the internationally coordinated label requirements, we refer to the International Medical Device Regulators Forum (IMDRF) document entitled ‘Guidance UDI - Unique Device Identification (UDI) of Medical Devices’.
Companies who use GS1 Standards & Keys for the creation and assignment of Unique Device Identifiers (UDI) in accordance to US FDA Rule on Unique Device Identification must declare their intention during their application and must maintain said information in the respective repositories.
Company shall be responsible for establishment registration, establishing and maintaining medical device listing and Global Unique Device Identification Database (GUDID) database, in each case, in the Territory.
The Authority can accommodate other Unique Device Identification Systems – the preference is GS1.
Supplier/ IdentifySensors is responsible for acquiring a Global Trade Item Number (GTIN) and Data Universal Numbering System UDUNS) and publishing the same to the Global Unique Device Identification Database (GUDID).