Clinical Investigation References
Clinical Investigation References werden im Zusammenhang mit einer Basis UDI-DI über den Basis UDI-DI Explorer (US17190) verwaltet.
Weitere Informationen sind unter Stammdaten UDI beschrieben.
Verwendung dieses Programms
- US17190 Basic UDI-DI
Felder
Clinical Investigation Reference
| Feldbezeichnung | Erklärung |
|---|---|
| Clinical Investigation Reference Number (non EU) | When registering the Device - where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation must be provided. Field stores the Clinical Investigation Number provided by the user when the Clinical Investigation is not registered in EUDAMED. |
| Country (non EU) | Countries outside EU were Clinical Investigation is performed. List of Countries were the Clinical Investigation has been performed. Field is optional and can be provided only for Clinical Investigations performed Outside EU (Non EU Countries only). If provided, the Clinical Investigation is considered to be NonEU Clinical Investigation. |
Überschriftsformat
| Feldbezeichnung | Erklärung |
|---|---|
| Basic UDI-DI | Device Identified code/value (DI Code). Together with the Issuing Entity creates the uniqness of the element to which they are assigned (Basic UDI-DI , UDI-DI, etc.). The Basic UDI-DI is the primary identifier of a device model.It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the 'access key' to information stored in a UDI database. The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together. |