Use an Excel or CSV article list for new registrations, with one article or device variant per row. Your identifiers should already be assigned under your issuing entity’s rules. UDI Studio does not create official UDI-DI or Basic UDI-DI codes.
Before you import
- Include a header row and three required columns: article number/reference, trade name (designation) and UDI-DI.
- Use the full UDI-DI from your issuing entity. For GS1, this workflow uses a 14-digit GTIN. UDI-DI from other issuing entities are not EAN-14 numbers.
- Add BUDI (Basic UDI-DI, the group identifier) and EMDN (the device classification code) per article if available. These file columns are recommended, not required.
Keep the table easy to import
Store identifiers as text in Excel to preserve leading zeros and prevent scientific notation. Avoid merged cells and extra title rows. In CSV, separate columns consistently with a semicolon, comma or tab. Ordinary spaces belong inside a value. Quote a value if it contains the delimiter.
Article number;Trade name;UDI-DI;BUDI;EMDN ARTICLE-001;Example mattress;ASSIGNED_UDI_DI;;
This illustrates the layout only; replace the placeholder with your actual assigned identifier.
After selecting the file
- Map your spreadsheet’s columns to the corresponding form fields. Header names do not need to match the example exactly.
- Check the imported rows and leading zeros. Review the trade name destined for the XML, including size removal or manual edits.
- Fill missing BUDI and EMDN values in the form. Optional file columns do not make those registration details optional. For existing-BUDI registration, the BUDI must already be registered under the selected regulation.
- Select the articles, complete their registration information and review before creating the XML. EUDAMED receives that XML, not your spreadsheet.