Touching lives without touching
Sleepiz One+ is the first EU MDR, Class IIa certified non-contact respiration monitor
Hornbachstrasse 23 | 8008 Zurich | Switzerland
Sleepiz AG Team Zürich and remote team (inset) celebrating the CE IIa certification
Press Release December 2021
ZÜRICH – Sleepiz AG, a Zürich-based medical technology start-up has received CE Class IIa certification, in accordance with the new European Medical Devices Regulations (EU MDR). This makes Sleepiz One+ the first certified non-contact device for vital sign monitoring in Europe.
Relentless efforts and a series of reviews on different expertise levels and clinical studies led Sleepiz AG to achieve the CE Class IIa certification for Sleepiz One+. With this certification, the EU MDR regulations intend to ensure a high standard of safety and quality for medical devices as well as standardizing data and technological advances.
For physicians, this certification implies that they can now prescribe Sleepiz One+ to their patients for short- or long-term respiration monitoring to receive better insights into their physiological status and the progress or remission of their disease.
For patients, this means that they can enjoy the comfort of their own home while being monitored with an easy to install and use wireless medical device at their bedside, knowing that their health status is being checked effortlessly, and continuously.