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EUDAMED

European Database on Medical Devices (EUDAMED)

The European database on medical devices is gradually replacing its predecessor, Eudamed2, with the MDR. What the databases have in common is that the data for medical devices collected by the individual EU states are collected centrally. Access is restricted to the national authorities. If the EUDAMED is not yet fully operational, Eudamed2 also fulfils other tasks.

Of primary interest is the application for the Single Registration Number (SRN) for medical device manufacturers via EUDAMED. The sooner this application is made, the sooner this number can be allocated. The same applies to the Unique Device Identification (UDI). The corresponding module is now available at EUDAMED.

Of course, manual entry has a weakness - the human factor. Data still must be collected, pre-validated and correctly entered in the appropriate places. However, some information is not so easy to gain or obvious to enter as to result in a standardised information base in EUDAMED from all manufacturers. Therefore, we offer to support you with the entry of your information regarding your company, your medical devices, or in vitro diagnostics into the EUDAMED database.