b-rayZ AG

b-rayZ AG specializes in digital breast tomosynthesis systems under the brand b-box plus. These devices are designed for three-dimensional imaging of breast tissue, enabling detailed visualization of breast abnormalities by capturing multiple thin slices. They are intended for use in diagnostic mammography to enhance detection and assessment of breast conditions.

b-rayZ AG is based in Switzerland, which is part of the European Economic Area (EEA). As a result, its devices must comply with EU medical device regulations, including mandatory registration in the EUDAMED database. Since its products fall under EU Class IIa, they require compliance with EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, depending on their classification.

Yes, b-rayZ AG’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures transparency and traceability for healthcare providers, regulators, and patients. It also demonstrates compliance with EU requirements, as manufacturers must register their devices to legally place them on the market.

b-rayZ AG’s devices are classified as EU Class IIa, which is the second-lowest risk category for medical devices. This classification means they pose a moderate risk and require compliance with specific EU regulatory controls, including clinical evaluations, risk management, and technical documentation. Class IIa devices must undergo conformity assessment procedures, such as a notified body review, before being placed on the market.