UMBRIA BIOENGINEERING TECHNOLOGIES SRL SOCIETA' BENEFIT

Umbra Bioengineering Technologies SRL manufactures the MammoWave, a breast lesion detection device. This device uses microwave imaging technology to identify abnormalities in breast tissue without exposing patients to ionizing radiation, distinguishing it from traditional imaging methods like mammography.

The company is headquartered in Italy, specifically in Umbria, as indicated by its name. This location is relevant for regulatory compliance and market operations within the European Union.

The company’s MammoWave device is listed in the eudamed database, which is the EU’s central registry for medical devices. This registration is required for compliance with EU Medical Device Regulations (MDR) and ensures transparency in the device’s market presence.

The MammoWave is classified as a Class IIa medical device under EU regulations. This classification is determined by factors such as the device’s intended use, risk level, and potential impact on patient safety, with Class IIa representing a moderate risk requiring additional scrutiny and conformity assessment procedures.