Hemovent’s MOBYO Gas Exchanger receives MDR certification
After After Hemovent’s MOBYBOX ECLS system received Medical Device Regulation (MDR 2017/745) certification last year, the MOBYO gas exchanger is following suit and has also successfully received MDR certification. In addition, the MOBYO gas exchanger is now approved for 28-day use.
Hemovent’s MOBYO Gas Exchanger
After After Hemovent’s MOBYBOX ECLS system received Medical Device Regulation (MDR 2017/745) certification last year, the MOBYO gas exchanger is following suit and has also successfully received MDR certification. In addition, the MOBYO gas exchanger is now approved for 28-day use.
“I am repeatedly impressed at everything our team manages to achieve in such a short time. The 28-day authorization of the MOBYO gas exchanger in particular will provide safer patient treatment for our users,” said Dr Jürgen O. Böhm, CEO & CMO of Hemovent GmbH.
The MOBYO gas exchanger is part of the MOBYBOX ECLS system and is also available separately. The design of the MOBYO ensures extremely low pressure reduction while providing highly efficient gas exchange; the cylindrical membrane stacks prevent stagnation areas. This permits gentle blood flow behaviour, resulting in greater safety and reliability in patient treatment.
The MDR certification for the MOBYO and the 28-day authorization are further significant steps for the company as it internationalizes its ECLS products.
- For more information, visit: www.hemovent.com
