Aditus Medical GmbH

Aditus Medical GmbH specializes in the CEMAD, a medical device primarily used in vascular access and catheterization procedures. It is designed for interventional radiology and related specialties, aiding in precise and controlled interventions within the vascular system. The device is tailored for clinical applications where accurate vascular access is critical.

Aditus Medical GmbH is headquartered in Germany. The company’s devices, including the CEMAD, are authorised for commercial distribution within the European Economic Area (EEA). This means the devices comply with EU regulatory requirements for market placement in these regions.

The CEMAD, manufactured by Aditus Medical GmbH, is listed in the EUDAMED database. EUDAMED is the European Union’s medical device registry, where manufacturers and devices authorised under EU regulations are recorded for transparency and traceability.

The CEMAD is classified as a Class IIb medical device under EU regulations. This classification is determined based on the device’s intended purpose, risks, and potential impact on patient safety. Class IIb devices require a higher level of scrutiny and conformity assessment than lower-risk classes, ensuring rigorous evaluation before authorisation.