
Dozee Secures CE Mark, Unlocks Global Markets for Remote Patient Monitoring and Early Warning Systems
Health-tech
innovator
Dozee
announced that it has secured
CE Mark
under the European Union Medical Device Regulation (EU MDR 2017/745), a gold standard for medical device safety and efficacy.
Already a recipient of US FDA 510(k) clearance for its proprietary contactless vital signs monitoring technology, Dozee's dual international certifications now firmly establish it as a globally trusted name in
Remote Patient Monitoring
(RPM) and
Early Warning Systems
(EWS)—two of the fastest-growing pillars in digital healthcare.
'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 access to quality healthcare to billions globally. Every signal captured, every insight generated, is designed to drive timely intervention and save lives.'
The CE Mark, granted by leading Notified Body TÜV SÜD, enables Dozee to market its products across more than 30 countries in the European Economic Area (EEA). It affirms the company's compliance with stringent regulatory benchmarks for safety, efficacy, clinical validation, and quality management.
Dozee's Class IIb MDR-certified system uses contactless sensors and
AI-driven algorithms
to track vital signs including heart rate, respiratory rate, SpO₂, blood pressure, temperature, and patient movement. These real-time, continuous insights allow healthcare teams to detect clinical deterioration early—helping reduce Code Blue events, prevent ICU admissions, and enhance overall patient outcomes.
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