MicroPort CRM receives CE mark approval for Alizea™ and ... | 合法醫療器材資訊網

2021年4月28日—MicroPort®CRMisapioneeringcompanyinthefieldofCardiacRhythmManagement(CRM),andasubsidiaryofMicroPortScientific ...

Clamart, France –April 28– MicroPort CRM, a pioneering company in the field of Cardiac Rhythm management, headquartered in France with global operations, announces it has received CE Mark approval under the new MDR (Medical Device Regulation – 2017/745) for its latest range of implantable pacemakers, AlizeaTM and BoreaTM, as well as for the SmartView ConnectTM home monitor. These devices are equipped with Bluetooth®1 technology for advanced wireless remote monitoring.

"We are very proud to be the first company to affix a CE mark to a range of pacemakers under the new European Medical Device Regulation (MDR)," said Vincent Leveaux, VP Product Development at MicroPort CRM. "TÜV SÜD Product Service GmbH, as the Notified Body, carried out the attestation of conformity under the new regulation and helped us to comply with all applicable regulations. The Declaration of Conformity gives an element of safet...