What is the EUDAMED SRN (Single Registration Number)?

A Single Registration Number is a unique identifier generated by EUDAMED that is issued to medical device legal Manufacturers, Authorized Representatives, and Importers involved in placing medical devices and IVDs on the European market following approval by the competent authority. It is the primary means of identifying these so-called “Economic Operators” (EO) in the EUDAMED database. Distributors are not assigned an SRN but a larger manufacturer with multiple legal entities placing devices on the European market might have multiple SRNs. Each economic operator is required to obtain a unique Action ID/SRN for each actor role which requires separate registration requests for each specific Actor ID/SRN role. An actor is a natural or legal person or organization with a specific role that requires registration in EUDAMED. The unique identifier generated by EUDAMED when the actor is a manufacturer, authorized representative or importer of medical devices or IVDs is called an SRN. All other actors, such as NBs, receive a unique identifier called an Actor ID. 

Are you a manufacturer trying to register for a EUDAMED certificate? MedEnvoy can assist you. Click here, for more information.

Requests for an SRN are submitted via EUDAMED and then reviewed by a national Competent Authority (Ministry of Health) who then issues the number. This portion of the EUDAMED database is called the “Actor Registration Module.” If a manufacturer is located outside of the European Union, their Authorized Representative will verify the registration request and then pass it along to the Competent Authority for review.  

The example below shows a hypothetical SRN for each of the four Economic Operators (EO), also known as Actors. The complete SRN consists of four letters followed by nine numbers. The first two letters are the ISO country code where the Economic Operator is based, followed by an abbreviation for the type of EO. The last nine digits are the unique SRN itself.

• • MF = Manufacturer

  • AR = Authorized Representative

  • PR = System & Procedure Pack Producer

  • IM = Importer

The example importer SRN above is for MedEnvoy Global BV, based in The Netherlands. You can search for Economic Operators on the EUDAMED database here.

Once a Single Registration Number is assigned to a device manufacturer it can be used in many places including:

• • Product registrations EUDAMED 
  • MDR or IVDR Declaration of Conformity  
  • Certificates issued by your Notified Body  
  • Referenced in your technical documentation  
  • Added to a Certificate of Free Sale 

Your Periodic Safety Update Reports (PSUR), field safety notices/corrective actions, incident reports and clinical reports will also reference it. Also, going forward any request for conformity assessment by a European Notified Body will require an SRN according to Article 31(3) of the MDR.

How MedEnvoy Can Support You

MedEnvoy offers hands-on support throughout your EUDAMED journey, from guiding you step-by-step in obtaining your Single Registration Number (SRN) to streamlining your device registration process for full compliance and peace of mind.