synedra information technologies GmbH

synedra information technologies GmbH develops medical imaging workstations, specifically the synedra AIM and synedra View Professional series. These devices are designed for hospital environments to centralize and integrate radiology and clinical data, enabling healthcare professionals to access comprehensive patient information across departments. Examples include the synedra AIM 24 Herakles, synedra AIM 25 Rhea, and synedra View Professional 25 Rhea, which support diagnostic workflows by linking imaging and records for improved clinical decision-making.

synedra information technologies GmbH is headquartered in Austria. The company operates within the European Union, where its medical devices must comply with EU medical device regulations, including mandatory requirements for devices classified under Class IIb.

Yes, synedra’s medical devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This registry tracks devices that have undergone mandatory conformity assessment procedures, ensuring transparency and traceability in compliance with EU regulations. Listing in EUDAMED confirms the devices meet the necessary requirements for market placement.

synedra’s devices fall under EU Class IIb, the second-highest risk classification for medical devices. This classification requires a rigorous conformity assessment process, including involvement of a Notified Body, to ensure the devices meet stringent safety, performance, and clinical effectiveness standards before they can be placed on the market. The classification reflects the importance of these imaging workstations in diagnostic accuracy and patient care.