A Single Registration Number (SRN) is a unique number assigned to your organization by a European Competent Authority. SRNs are only issued to companies ( ‘Economic Operators’ ) that require registration in EUDAMED, which is the European Database on Medical Devices. The SRN is then made available on EUDAMED’s public website.
The purpose of the SRN is for better traceability and transparency of economic operators and devices associated with them.
Economic Operators that require an SRN are:
Manufacturers (both non-EU and EU-based manufacturers)
System & Procedure Pack Producers
Authorized Representatives
Importers
If your organization is not an Economic Operator that must register in EUDAMED, then you do not need, and cannot get, an SRN. For example, distributors are Economic Operators according to the MDR/IVDR. However, distributors are not required to register in EUDAMED, and therefore do not receive SRNs.
See our Economic Operator EUDAMED registration page for more details on the process.
Note that Economic Operators are referred to as ‘Actors’ in EUDAMED, which is why the SRN registration section of EUDAMED is called the Actor Registration module.
What if I only have MDD/AIMD/IVDD devices? Do I still need an SRN?
If your organization is associated only with MDD/AIMD/IVDD ‘legacy’ devices, and not with any MDR/IVDR CE marked devices, you are still required to register in EUDAMED, once EUDAMED becomes mandatory. However, you will be issued an Actor Identifier (ID), instead of an SRN. The Actor ID and the SRN look the same, and practically speaking, have the same function.
