Eudamed Registration

It is not EUDAMED fee in reality. EUDAMED itself is not an decision based portal, it is mediator of information from Authorities and Operators.
Though your intended country CA (Competent Authority) charge for registration as an economic operator.
When you are done with CA registration process, Then go for EUDAMED, you won't be charged

Hi all
Happy new year.
We register our company in Eudamed data base and then we try to register our CE marked product (MDD certificated), but there is not any part that we can register our product . you can see our dashboard as attached below.

Hi Doninina,

Are you trying to register the UDI-DI? If so, you need to have access as a LAA or Confirmer to do this

I have an issue with EUDAMED too, I hope someone can help -

I am using GS1 to generate our UDI, this is what GS1 call a GTIN-13. When I enter the GTIN-13 plus a leading 0 to make up the 14 digits required by EUDAMED all I get is an error saying "Value provided does not respect the requested format or is not passing the check-digit validation."

Has anyone any ideas on how to proceed?

StepPCHen said:

Hi Doninina,

Are you trying to register the UDI-DI? If so, you need to have access as a LAA or Confirmer to do this

Click to expand...

Yes , first I try to register device in Eudamed but there is not any option.

I came across an issue with the database/amending a product name about 2 years ago.... I suggest you email the EUDAMED helpdesk with details of the problem.