Dozee, a provider of Remote Patient Monitoring (RPM) and Early Warning Systems (EWS), has announced that it has received the CE Mark under the European Union’s Medical Device Regulation (EU MDR 2017/745). This certification allows Dozee’s clinically validated vital signs monitoring system to be marketed across more than 30 countries in the European Economic Area (EEA).
According to the company, the CE Mark is a significant regulatory achievement that supports Dozee’s mission to bring clinically compliant and scalable healthcare solutions to diverse global settings. The company had previously received US FDA 510(k) clearance in 2022 for its contactless vital signs monitoring technology.
“CE Mark positions Dozee among a select group of global health-tech innovators whose solutions meet stringent international standards while driving real-world impact,” said Gaurav Parchani, CTO & Co-founder of Dozee. “We’re building world class infrastructure to provide access to quality healthcare to billions globally. Every signal captured, every insight generated, is designed to drive timely intervention and save lives. That’s how we turn engineering into impact—by designing systems trusted across borders, and built for humanity.”
The CE Mark, issued by TÜV SÜD—a Notified Body under EU MDR—follows an evaluation of Dozee’s quality management system, technical documentation, and clinical validation data. The certification classifies Dozee’s solution under Class IIb medical devices.
Dozee’s system is designed to monitor key vital signs including heart rate (HR), respiration rate (RR), non-invasive blood pressure, temperature, oxygen saturation (SpO₂), and patient movement. Using contactless sensors and proprietary algorithms, the system enables healthcare providers to detect early signs of deterioration and make timely interventions.
The company currently operates in over 300 hospitals and care centres across India, the United States, Africa, and the UAE. Dozee reports that its systems have helped reduce Code Blue events, enable earlier interventions, decrease the length of stay in critical care, and support care teams in delivering more efficient patient management.
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