UDI Measure Units
UDI Measure Units indicate the unit in which the values of the respective clinical variable are to be specified and evaluated.
The Measure Units page is accessed using Tell Me. Choose the
icon, enter Measure Units, and then choose the related link. Choose the New action to add a measure unit or Edit List action to edit existing measure units.
| Field | Description |
|---|---|
| Code | Specifies a unique code for the UDI measure unit. |
| Description | Specifies a description for the UDI measure unit. For custom codes to be exported to EUDAMED, the description must be in English. |
| Category | Specifies the UDI size category the record belongs to. |
| FDA Code | Specifies the code that will be used for export to GUDID. If no FDA code is defined, then the measure unit is not considered for export. |
| EU Code | Specifies the code that will be used for exporting to the EUDAMED database. It must begin with "MU", followed by digits. The default value for custom measure units is MU999. If no EU code is defined, then the measure unit is not considered for export. |
The UDI Measure Codes are used in clinical sizes, storage and handling types, and UDI-DI storage conditions. Users can add default codes, delete unused default codes, and add their own codes.
Tip
Use the predefined views to filter the page to Default or Custom codes.
Insert Default Codes
Choose the Insert Default Codes action to insert measure unit codes of different categories predefined by the app.
If there is already a code with an identical name, it will not be updated. This means that accidentally deleted default codes can be restored at any time by using this function.
Note
Default measure units can also be created by choosing Actions > Insert Default Codes on the Unique Device Identification Setup page. However, this function also adds UDI Symbol Codes, UDI Sterilization Methods, and UDI Size Types.
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