Breas Medical Limited

Breas Medical Limited specializes in disposable breathing circuits and related accessories. Their portfolio includes 22mm breathing circuits designed for use with ventilators and masks, as well as specialized circuits for intermittent positive-pressure breathing (IPPB), non-invasive ventilation (NIV), and cough assistance. They also produce internal battery-powered devices like the Clearway 2 and catheter mount assemblies with exhalation ports.

Breas Medical Limited is headquartered in the United Kingdom (UK). The company’s location is relevant for regulatory and operational purposes, particularly when assessing compliance with UK and EU medical device regulations.

Breas Medical Limited’s devices are listed in the eudamed database, which is the official EU registry for medical devices under the EU Medical Device Regulations (MDR). This registry ensures transparency and traceability of devices authorized for use within the European Economic Area.

Breas Medical Limited’s devices fall under Class I, Class IIa, and Class IIb classifications according to the EU Medical Device Regulations. Classification determines the regulatory requirements for device authorization, with higher classes (e.g., IIb) typically requiring more rigorous scrutiny due to increased risk. For example, breathing circuits and specialized circuits for NIV or IPPB are often classified as higher risk due to their direct interaction with patients’ airways.