EUDAMED Bulk XML & UDI Device Registration Support
EUDAMED bulk XML preparation is a critical step for medical device manufacturers, authorised representatives and exporters who need to organise device registration data in a structured and compliant format. Preparing UDI-DI, Basic UDI-DI, EMDN code, risk class, device model, catalogue reference and manufacturer information correctly helps reduce registration errors and supports a smoother EUDAMED device registration process.
KaliteKit provides EUDAMED bulk XML and UDI device registration support for companies managing multiple medical devices, product variants or large device portfolios. The service focuses on data review, Excel template preparation, missing field identification, consistency checks and XML-ready device registration data structuring.
For companies with many UDI-DI records, manual data preparation can create a high risk of duplication, missing information or inconsistent device grouping. A structured EUDAMED bulk XML approach helps manufacturers organise their device data more efficiently before submission.
KaliteKit supports the preparation and review of key EUDAMED data elements including Basic UDI-DI, UDI-DI, EMDN code, device trade name, model, catalogue reference, risk class, regulatory status, packaging information and internal product notes. This support is especially useful for companies preparing bulk registrations or validating their data before upload.
If your company needs support for EUDAMED bulk XML preparation, UDI device registration data review or Excel-to-XML structuring, KaliteKit can help you prepare a more consistent and controlled registration dataset. For official information about EUDAMED, companies should also review the European Commission’s EUDAMED resources.
EUDAMED Registration Support for Global Medical Device Manufacturers
We help non-EU and international medical device manufacturers prepare structured UDI/Device data, validate MDR-related information and generate EUDAMED-ready bulk XML files for faster, cleaner and more controlled registration workflows.
What We Do
A practical service for manufacturers, regulatory teams, authorised representatives and distributors who need clean, structured and registration-ready EUDAMED device data.
EUDAMED Data Preparation
We review and structure your device data including Basic UDI-DI, UDI-DI, device names, risk class, intended purpose, EMDN code and market information.
Bulk XML Generation
We convert large Excel-based product catalogues into EUDAMED-ready bulk XML files to reduce manual work and registration errors.
MDR Readiness Review
We check consistency between your EUDAMED data, Declaration of Conformity, labels, IFU and technical documentation.
Simple Project Flow
Designed for companies with multiple devices, large catalogues and limited time before EUDAMED deadlines.
Send Your Data
Share your Excel list, product catalogue or current UDI/device registration data.
We Review Gaps
We identify missing, inconsistent or risky fields before registration.
Data Mapping
Your product data is mapped into a structured EUDAMED-ready format.
XML Preparation
We prepare bulk XML files and support your registration workflow.
Request a Free 10-Device EUDAMED Data Check
Send us basic information about your company and device catalogue. We will review up to 10 devices and show how your data can be prepared for EUDAMED bulk registration.