Service Details

UDI and Eudamed Registration

We manage the acquisition and implementation of the UDI code and the validation of the printing process. We obtain the SRN for economic operators and register medical devices in the Ministry of Health database and in Eudamed, also providing solutions for bulk uploading.

Context and Introduction

Each medical device must be identified by a Unique Device Identifier (UDI) whose management is regulated by regulatory requirements. Furthermore, economic operators must fulfill obligations regarding registration in Eudamed and notification to national competent authorities before placing a medical device on the market.

UDI acquisition and implementation

We handle the acquisition of the UDI code by interfacing with issuing bodies and support the client in implementing the obtained codes and validating the printing process.

SRN acquisition

We manage the registration of economic operators such as manufacturers, importers, and authorized representatives in Eudamed in order to obtain the Single Registration Number (SRN).

Eudamed registration

We set up the organization’s accounts assigning roles suitable for registration. We provide tools to collect and organize information on medical devices to be registered. We register Basic UDI-DIs and UDI-DIs in Eudamed using manual and bulk upload methods.

Database registration

We handle the registration of medical devices in the Italian Ministry of Health database, including bulk upload methods. We manage the fulfillment of notification obligations for placing products on the market in European Union countries.

Needs Analysis

Use the contact details in the contacts section: we can provide more details, arrange an introductory meeting, structure a tailored service, and define a dedicated economic offer.