Dozee Secures CE Mark for Remote Monitoring Tech, Expands to Over 30 Countries

This certification allows the company to expand the reach of its Remote Patient Monitoring (RPM) and Early Warning Systems (EWS) in global healthcare markets.

Bengaluru-based health-tech firm Dozee has received the CE Mark under the European Union Medical Device Regulation (EU MDR 2017/745), enabling it to market its products across over 30 countries in the European Economic Area (EEA).

The CE Mark, granted by Notified Body TÜV SÜD, confirms Dozee’s compliance with international safety standards, efficacy, clinical validation, and quality management. 

This certification allows the company to expand the reach of its Remote Patient Monitoring (RPM) and Early Warning Systems (EWS) in global healthcare markets.

Dozee’s system, now certified as a Class IIb medical device under MDR, integrates contactless sensors with AI-powered algorithms to monitor heart rate, respiratory rate, SpO₂, blood pressure, temperature, and patient movement. The platform delivers continuous, real-time insights to help clinicians detect early signs of deterioration, potentially reducing Code Blue events and ICU admissions.

“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 and Co-founder of Dozee. “We’re building world-class infrastructure to provide billions of dollars globally with access to quality healthcare. Every signal captured, every insight generated, is designed to drive timely intervention and save lives.”

The company received clearance from the US FDA 510(k) for its contactless vital signs monitoring technology. With both CE and FDA approvals, Dozee’s platform is now backed by dual international regulatory validations.

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