EUDAMED UDI Bulk Upload
Batch generate EUDAMED XML upload files for medical device manufacturers with many UDI-DI codes.
Background
Since May 28, 2026, the EUDAMED UDI/Devices module is mandatory (Commission Decision (EU) 2025/2371). All new devices must register UDI before market placement; existing devices must complete registration by November 28, 2026.
Workflow
Upload Excel → AI Parse/Map → Preview/Confirm → Generate XML → Download ZIP- Upload Excel -- supports custom formats and standard template
- Data Validation -- checks required fields, GS1 format (14-digit zero-padded)
- Preview -- table view of parsed results, editable
- Generate XML -- EUDAMED XSD v3.0.28 compliant, auto-splits at 40 identifiers
- Download ZIP -- ready for EUDAMED Bulk Upload interface
Technical Constraints
| Constraint | Detail |
|---|---|
| XSD Version | v3.0.28 |
| Per-file limit | 40 device identifiers |
| GS1 format | 14-digit zero-padded |
| Services | DEVICE.POST + UDI_DI.POST |
Available on: All plans