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EUDAMED Registration, Handled End to End

Actor registration, device data and UDI (Unique Device Identification) — completed, verified and maintained.

Scope

What’s Included

  • Actor registration for manufacturers, authorised representatives and importers — including the Single Registration Number (SRN)
  • UDI-DI assignment and Basic UDI-DI creation
  • Device registration
  • Certificate and Notified Body data entry
  • Technical documentation module preparation
  • Verification and maintenance

Fit

Who It’s For

  • Manufacturers registering for the first time
  • Non-EU manufacturers working through EU representatives
  • Portfolios whose existing data needs cleanup

Deliverables

What You Receive

  • Completed registrations in the applicable modules
  • UDI-DI assignment documentation
  • Confirmations and tracking

Limits

What’s Not Included

  • Issuing agency accounts and fees (e.g. GS1) — you contract directly with the issuing entity
  • Label artwork and UDI carrier implementation on packaging
  • Competent authority validation times — outside anyone’s control

Timing

Indicative Timelines

Actor registration is typically completed within a few weeks; competent authority validation times vary. Device registration depends on portfolio size.

Ready to Get Registered?

Free initial consultation · Response within 24 hours · No obligation

Regulatory information last reviewed: 10 August 2026