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Proramillenote:
the EUDAMED
accredited partner
for your ADV

Eudamed accredited
importers of
Medical Devices Class 1

Proramillenote is Eudamed accredited for the importation of MD Class I.

Proramillenote
Accredited
Eudamed Partner

We are importers of
Class I Medical Devices
accredited by EUDAMED.

Proramillenote,
pharma ADV specialist
since 1972

Why we are an Eudamed partner:
the role of "EUDAMED"

Here we unveil the acronym EUDAMED: EUropean DAtabank for MEdical Devices. It is one of the fundamental pillars of the new regulations on medical devices and in vitro diagnostics. This European database, effective from 2024, collects and processes information regarding medical devices on the market, economic operators in the sector, accredited bodies, clinical investigations, vigilance, and surveillance.

Proramillenote is an accredited EUDAMED partner for the importation of Class I Medical Devices into Italy and Europe

Marketing While Respecting Stakeholders

With this choice, we renew our commitment to accuracy, safety, and transparency in our supplies, quality offered in support of your Ethical marketing.

Operator code EUDAMED Proramillenote SRN IT-IM-00032942

PRORAMILLENOTE-EUDAMED-SRN-IT-IM-000032942

EUDAMED is an important tool for the safety and quality of Medical Devices in Europe. The database facilitates information sharing and collaboration among stakeholders, contributing to improving the health and safety of European citizens.

Accredited EUDAMED - Operator code
Proramillenote SRN IT-IM-00032942

How does Eudamed work?

EUDAMED performs various essential functions, including:

  • Information Collection and Processing: EUDAMED contains information on medical devices, economic operators, and notified bodies like Eudamed partners, clinical studies, vigilance, and surveillance.
  • Transparency and Visibility: The database provides information on medical devices to the public, healthcare professionals, and competent authorities.
  • Improvement of Patient Safety: EUDAMED facilitates sharing information on the safety of medical devices, helping to identify and manage risks promptly.
  • Protection of Public Health: Ensures the safety and quality of medical devices placed on the European market.

Database Content: Six Modules

EUDAMED is divided into six modules:

  • Actors: Information about economic operators, including manufacturers, importers, and distributors, Eudamed partner
  • Devices: Information about medical devices, including technical specifications and technical documentation.
  • Certificates: Information about certificates issued by notified bodies.
  • Clinical studies: Information about clinical studies conducted on medical devices.
  • Surveillance: Information about adverse events and corrective actions.
  • Market surveillance: Information about market surveillance activities conducted by competent authorities.

Access

EUDAMED is accessible to various types of users, including:

  • Economic operators: Eudamed partners, manufacturers, importers, and distributors can use EUDAMED to register their devices and access information about devices and notified bodies.
  • Competent authorities: Competent authorities can use EUDAMED to monitor medical devices, conduct inspections, and manage corrective actions.
  • Public: The public can access information about medical devices, economic operators, and clinical studies.