Prepared and submitted by engineers who use EUDAMED daily for their own devices.
EUDAMED is the European database for medical devices. Before your devices can appear in it, both your company and your authorised representative must be registered as actors and hold a Single Registration Number (SRN).
We handle actor registration, verify or create your Basic UDI-DI and UDI-DI records, and register the authorised representative mandate that links your company to ours.
We are not learning this at your expense. Medex is itself a medical device manufacturer with its own SRN (TR-MF-000057496) and its own devices registered in EUDAMED. The people who file our records will file yours.
One device equals one Basic UDI-DI. Unlimited UDI-DI variants under the same Basic UDI-DI are covered by the base fee, and the first ten UDI-DI entries are included.
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