Your UDI data. Connected worldwide.

With our Global Submission Portal, you can validate and submit UDI data from Excel to EUDAMED, FDA GUDID, swissdamed, and TGA AusUDID.

Discover the Global Submission Portal

One SAP solution. Multiple UDI databases.

Manage, validate, and submit your UDI data directly from SAP—with modular connections to international UDI databases.

Discover the Global UDI SAP Add-on

Submit UDI data securely.

Whether from SAP, XML, or Excel: we transform, validate, and securely submit your UDI data to international regulatory databases.

Explore UDI data submission

Implement UDI compliance with confidence.

From strategy through system integration, we combine regulatory requirements with practical UDI processes.

Explore UDI consulting

We combine UDI expertise, SAP integration and custom software development to create secure, practical solutions for your regulatory processes.

UDI and MedTech Consulting

We support MedTech companies from UDI strategy through system integration—with specialist, technical, and practical expertise.

Global UDI Submission Portal

Validate UDI data from Excel and securely submit it to EUDAMED, FDA GUDID, swissdamed, and other target systems.

Global UDI Management

Manage, validate, and approve UDI data directly in SAP—with modular connections to international regulatory systems.

UDI Excel Cloud Validator

Validate UDI Excel files for EUDAMED and GUDID directly in your browser—with row-level feedback.

GS1 Barcode Generator for SAP

Generate GS1 DataMatrix, GS1 Code 128, and other barcodes directly in SAP and flexibly integrate them into your forms.

Software Development

From concept to implementation: custom software solutions with flexible teams and direct collaboration.

We value every single one of our customers and guarantee individual solutions for every SAP project. Reliability and competence are the decisive factors for a successful cooperation

What our customers say

Feedback from our customers and participants sets the direction for our actions. Participant surveys are therefore an essential element of our quality management

When the UDI requirements of the FDA were introduced in 2016 with the Global Unique Device Identification Database (GUDID), we decided on the solution of being able to manage our UDI data independently using a SAP add-on, maintain it in SAP and transfer it from there to the database. Mr. Demiralp and his team were able to implement this solution successfully, so that we were more than satisfied then and still are.

For us it was also within the framework of the UDI requirements of the European database for Medical products (EUDAMED) it is important to continue on this path of independent data management and transfer from SAP. That's why we decided this time to use the EUDAMED SAP Add-On from Europe IT Consulting.

Regulatory Affairs - Company Dentaurum

At seca, quality and efficiency come first. With the support of Europe IT Consulting GmbH in SAP and Adobe form development, we have a significant increase in both aspects achieved.
The integration of their FDA and EUDAMED Add-On was a seamless process, and the benefits we derive from it are visible every day.

A big thank you to the team from Europe IT Consulting for their excellent work and support!

Head of IT & ERP - Company seca gmbh & co. kg

Here you will find the latest news

6. October 2026

EUDAMED Certificates for UDI Registration: What is Required?

By Ugur Müldür in Technical article

EUDAMED · MDR · UDI/Devices EUDAMED: Which certificates must be provided during UDI device registration? Technical article · Last updated: 6 October 2026 Medical device manufacturers may hold several certificates issued by a Notified Body as part of their MDR conformity assessment. However, when registering a device in the EUDAMED UDI/Devices Module, not every existing […]

2. October 2026

New free UDI calculator

By Ugur Müldür in News

Calculate GTIN-14, GMN, Master UDI-DI and HIBC Basic UDI-DI directly in your browser Correctly creating UDI identifiers is one of the fundamental tasks in UDI data management. Depending on the Issuing Entity used and the type of identifier, however, different structures and methods apply for calculating the required check characters. Europe IT Consulting therefore provides […]

30. September 2026

Master UDI-DI: Contact Lens Requirements and EUDAMED

By Ugur Müldür in News

Last updated: 30 September 2026 The Master UDI-DI groups specified highly individualised medical devices according to relevant design parameters. It reduces the number of identifiers to be registered in EUDAMED while retaining the information needed for traceability. Contact lenses and spectacle products have separate implementation dates and technical registration arrangements. [1] Key implementation dates Product […]

Show more News

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Your UDI data. Connected worldwide.

One SAP solution. Multiple UDI databases.

Submit UDI data securely.

Implement UDI compliance with confidence.

Our solutions for UDI and MedTech

UDI and MedTech Consulting

Global UDI Submission Portal

Global UDI Management

UDI Excel Cloud Validator

GS1 Barcode Generator for SAP

Software Development

Here are some references.

What our customers say

Regulatory Affairs - Company Dentaurum

Head of IT & ERP - Company seca gmbh & co. kg

News

EUDAMED Certificates for UDI Registration: What is Required?

New free UDI calculator

Master UDI-DI: Contact Lens Requirements and EUDAMED

Would you like to stay informed about news in the field of UDI and Medtech?
Then sign up for our monthly newsletter.

Your UDI data. Connected worldwide.

One SAP solution. Multiple UDI databases.

Submit UDI data securely.

Implement UDI compliance with confidence.

Our solutions for UDI and MedTech

Here are some references.

What our customers say

Regulatory Affairs - Company Dentaurum

Head of IT & ERP - Company seca gmbh & co. kg

News

Would you like to stay informed about news in the field of UDI and Medtech? Then sign up for our monthly newsletter.

Would you like to stay informed about news in the field of UDI and Medtech?
Then sign up for our monthly newsletter.