Hemovent Receives MDR Certification for its MOBYBOX™ ECLS System

It’s done! Hemovent successfully completed the Medical Device Regulation (MDR 2017/745) certification process for its MOBYBOX™ system. The MOBYBOX™ already received the CE mark according to MDD (93/42/EEC) for the European market in 2019. A further step towards future expansion has thus been made.

“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. And we are excited that we can now focus on opening up new markets for our ECLS product abroad,” said Dr. Jürgen O. Böhm, CEO & CMO of Hemovent GmbH.

The MOBYBOX™ is the first ECLS device that uses only pneumatic power as its energy source and integrates both blood flow control and gas management into a single device. It does not require complex software and it weighs only 2 kg. The innovative Bionique Flow Technology provides gentle treatment of blood and is unique in ECLS application. So it is not surprising that Hemovent, with its MOBYBOX™, was crowned the winner of the Aachen Innovation Award in 2021. “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,” continued Dr. Böhm.  

Über die Hemovent GmbH

Hemovent is an emerging medical device company based in Aachen, Germany that has won multiple awards. Its MOBYBOX™ product is an extremely portable machine that easily fits in a backpack and is even easier to operate. With this highly innovative ECLS system, Hemovent wants to expand the application area of this life-saving technology for heart-lung support to a fully new dimension. Since 2021, Hemovent has been focusing on growth and aims to shape the future of the portable ECLS system market in intensive care medicine over the long term as a member of MicroPort®, a global medical devices company operating in multiple international markets.

Firmenkontakt und Herausgeber der Meldung:

Hemovent GmbH
Pascalstr. 59
52076 Aachen
Telefon: +49 (241) 9901330
http://hemovent.com

Ansprechpartner:
Sandra Bastian
Manager Marketing & Communication
Telefon: +49 (241) 990133-27
E-Mail: sbastian@hemovent.com
Für die oben stehende Story ist allein der jeweils angegebene Herausgeber (siehe Firmenkontakt oben) verantwortlich. Dieser ist in der Regel auch Urheber des Pressetextes, sowie der angehängten Bild-, Ton-, Video-, Medien- und Informationsmaterialien. Die United News Network GmbH übernimmt keine Haftung für die Korrektheit oder Vollständigkeit der dargestellten Meldung. Auch bei Übertragungsfehlern oder anderen Störungen haftet sie nur im Fall von Vorsatz oder grober Fahrlässigkeit. Die Nutzung von hier archivierten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem angegebenen Herausgeber. Eine systematische Speicherung dieser Daten sowie die Verwendung auch von Teilen dieses Datenbankwerks sind nur mit schriftlicher Genehmigung durch die United News Network GmbH gestattet.

counterpixel