AZ RegDocs

EUDAMED Express — SRN and device registration

Actor registration (SRN) plus up to 5 devices in EUDAMED. Data checklist, field mapping, expert verification and a final report — fixed price.

€2,500up to 5 devices · +€350/device beyond scope

3–5 business daysafter complete client data

Request the EUDAMED Express checklist WhatsApp

Who it is for

Medical device manufacturers (PL / CEE / EU)
Importers and Authorized Representatives
System / procedure pack producers
Teams without in-house EUDAMED capacity

Who it is not for

“Do it for us” without LAA / EU Login data
National distributors with no EUDAMED role
Expecting a guaranteed CA approval timeline

Scope

Actor + UDI data checklist (up to 5 devices)
EUDAMED field mapping
Expert verification by Alicja Załanowska
Submit support (EU Login stays with the client)
Final report + update guidance

FAQ

Do you guarantee SRN within X days?

No. Timelines depend on the competent authority. We prepare a complete, consistent submission and support the process — without promising CA decision dates.

Who clicks Submit in EUDAMED?

Submit and EU Login remain with the client (LAA). We prepare data, mapping and verification.

Devices beyond five?

+€350 per additional device (amendment). Larger packs are quoted individually.

Facing an EUDAMED deadline?

Write to us — we reply within 3 business days with a checklist and scope confirmation.

Request checklist How to get an SRN in Poland

AZ Regulatory is not a notified body, law firm or certifying authority. Advisory and documentation service only. SRN decisions belong to the competent authority. No guarantee of registration outcome or CE certification.