Paste the UDI information you already have in any format. AI organizes the device records; deterministic checks then render, preview, and package the EUDAMED XML.
The agent reads prose, copied tables, CSV, TSV, JSON, and mixed labels.
The agent must leave unsupported UDI, EMDN, class, and SRN values blank instead of guessing.
Generate DEVICE Push files and automatically respect batch limits.
Tables, prose, JSON, labels, or mixed notes.
Pi maps the material into canonical UDI fields.
Deterministic checks render EUDAMED XML.
Paste copied spreadsheet rows, JSON, product records, label text, or ordinary notes. The agent interprets the structure; you do not need to match a fixed template.
From 28 May 2026, the UDI/Device registration module is mandatory. The European Commission supports manual entry, XML upload/download through the user interface, and full machine-to-machine data exchange. This free utility targets the middle path: prepare structured records in a spreadsheet and generate XML for the logged-in bulk-upload screen.
The input step accepts flexible source formats. The output step is intentionally deterministic: after AI organizes the records, fixed checks preserve XML tags, field order, batch limits, and the Production contract. Unsupported EMDN codes, UDI-DIs, SRNs, risk classes, and market facts stay blank. Confirm every extracted record before upload.
Use the free tool for structured preparation. When you need EUDAMED record review, EU representation, dossier coordination, or registration across multiple markets, talk with our regulatory team.
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It creates DEVICE POST Push XML for the semi-automated EUDAMED user-interface bulk-upload flow using the Production 3.0.30 message contract. It supports MDR, IVDR, system or procedure pack, and legacy device rows.
No. It creates XML files for you to review and upload while signed in to EUDAMED. It does not log in, transmit data, or perform machine-to-machine submission.
Yes. Paste prose, copied spreadsheet cells, CSV, TSV, JSON, or mixed labels. The AI maps explicit facts into structured UDI records. Pasted material is processed by Pure Global and its AI provider for this run; do not include patient-identifying or unauthorized confidential information.
No. The preflight catches common required-field, enumeration, duplicate, boolean, and market-information issues. EUDAMED applies its current XSD, enumerations, business rules, actor data, and record-level checks during upload.
The tool keeps each generated Push at no more than 300 Device entities and splits larger lists or oversized XML into multiple files. Multiple output files are downloaded together as a ZIP.
Spreadsheet software can remove leading zeros or convert long identifiers to scientific notation. Formatting identifier columns as text preserves the exact UDI-DI value needed in XML.
