Hemovent Receives MDR Certification for Its MOBYBOX™ ECLS System

Aachen, Germany, 6 May 2023 - Recently, Hemovent GmbH (Hemovent) announced that its Extracorporeal Life Support (ECLS) product, the MOBYBOX™ system (MOBYBOX™), completed the EU Medical Device Regulation (MDR) certification process. In 2019, MOBYBOX™ was awarded the CE mark under the European Medical Device Directive (MDD). The MDR establishes a more stringent regulatory system for medical devices compared to the MDD.

Dr. Jürgen O. Böhm, CEO & CMO of Hemovent, stated: “We are pleased to see the excellent quality of our product confirmed once again with the successful MDR certification, thus maintaining its validity beyond the MDD certificate. We are excited to now focus on opening up new markets for our ECLS product abroad.”.

MOBYBOX™ is the first ECLS device that uses only pneumatic power as its energy source, integrating both blood flow control and gas management into a single device. This small product weighs only 2kg and does not require complex software. Its innovative Bionique Flow Technology provides gentle treatment of blood and is unique in ECLS application. In 2021, Hemovent won the Aachen Innovation Award with MOBYBOX™. Dr. Böhm continued: “We are very proud of our successes to date and of our staff, who made all this possible in the first place. It is great to see everyone working towards a joint goal. At the moment, we are concentrating on expanding our portfolio and internationalizing our products. And, thanks to our strong team, I am absolutely confident that we will continue to successfully accomplish the upcoming projects.”.

About Hemovent

Hemovent is an innovative medical device company located in Aachen, Germany, and has won multiple awards. Its product, MOBYBOX™, is small and portable, easily fitting into a backpack and simple to operate. Through this highly innovative ECLS system, Hemovent aims to take life-saving heart-lung support technology to a new level. Hemovent is always dedicated to research and development, striving to constantly lead and shape the future of portable ECLS systems in critical care medicine.

About MicroPort® Surgical

Hemovent is a wholly owned subsidiary of MicroPort® Surgical, which is operated and managed by Shenzhen MicroPort Medical (Group) Co., Ltd. Leveraging its 30 years of technical accumulation in the field of cardiopulmonary bypass (CPB) in cardiac surgery, MicroPort® Surgical actively expands its applications in areas such as artificial heart, extracorporeal life support, extracorporeal carbon dioxide removal (ECCO2R), critical care technology, and intelligent decision support systems. The company is committed to providing patients with comprehensive medical solutions for end-stage heart disease and critical illnesses. By using the world's first integrated, portable, and non-electric MOBYBOX™ product, the company is dedicated to building a new configuration of a mobile critical care unit system that focuses on ECMO pre-hospital emergency care and is suitable for air and ground transportation. The goal is to continuously improve the treatment efficiency and success rate of critical illness patients.

Hemovent is the European research and development and production base of MicroPort® Surgical, making full use of the medical and technological resources of Aachen, Germany. It is an important part of MicroPort® Surgical's overall layout for the solution of critical illnesses.