SRN Number

The Single Registration Number (SRN Number) identifies every economic operator in EUDAMED and outside of EUDAMED. The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN). The SRN is issued once the relevant competent authority has validated the Actor registration request.

These SRN is reflected on Medical Device documents like technical files, DOC, CE Certificate, Summary of safety and clinical performance, Analysis of serious incidents and field safety corrective actions.

An actor is a natural or legal person with a specific role that has to be registered in EUDAMED.

Economic Operators are Manufacturer, Authorised representative, System & Procedure pack producer and Importer.

For EU Economic Operators

• Actors shall register in Eudamed.
• EU-based economic operators shall select the Competent Authority in the Member State where they are based.
• Competent Authority can confirm that registration after validating the request.
• SRN is received to Actor via Email-Id.

For Non-EU Economic Operators

• Actors shall register in Eudamed.
• Non-EU manufacturers shall select the Competent Authority in the Member State where their Authorized Representative is based.
• Manufacturers based outside the EU shall ensure their Authorized Representatives register with Eudamed as an Economic Operator, who will receive a notification of that registration request.
• Once Authorized Representative has confirmed the mandate, the Competent Authority will receive the registration request.
• SRN is received to Actor via Email-Id once competent authority validate the registration request.

• Assist in providing an official European Authorized Representative who is already registered as Actor Module in Eudamed involved in verifying the registration request before passing it to the national competent authority for assessment.

For example: If manufacturer ABC is situated in Austria and acting as manufacturer, then SRN will be issued only for the Manufacturer role. If manufacturer ABC is situated in Austria and acting as manufacturer as well as Importer, then two SRN will be issued one for Manufacturer role and second for importer role.