Certificate Links
Certificate Links 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
Certificate Link
| Feldbezeichnung | Erklärung |
|---|---|
| Certificate Number | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Number of the Product Certificate. |
| Certificate Type | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property defines the type of Product Certificate associate with the Device. The expressions are stored in the table FRDY08 (Certificate Type (EU)). |
| Certificate Status | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Status of the Product Certificate. The expressions are stored in the table FRDCCS (Certificate Status). |
| Notified Body | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the reference to the Notified Body (in Table FRDNBO (Notified Bodies (Benannte Stellen))) that issued the Product Certificate. |
| Revision Number | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Revision Number of the Product Certificate. |
| Issue Date | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Issue Date of the Product Certificate. |
| Starting Validity Date | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Starting Validity Date of the Product Certificate. |
| Expiry Date | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Expiry Date of the Product Certificate. |
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. |