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Major Milestone | Witleaf Secures EU MDR Certification, Ushering in a New Chapter for Global Medical Monitoring
2026/04/07
Witleaf Team
Recently, the series of products including patient monitors, vital signs monitors, EtCO₂ monitors, etc., of Witleaf have obtained the MDR certificate in accordance with EU Regulation (EU) 2017/745 (MDR), certified by the EU Notified Body TÜV SÜD (Certificate No.: G15 005136 0007). This marks that the company's entire chain, including product design and development, manufacturing, quality control and full lifecycle management, has fully met the requirements of the latest EU medical device regulation, and its quality and compliance capabilities have once again obtained international authoritative recognition.
From Building Core Technology to Meeting Global Standards

Since its founding, Witleaf has remained committed to independent R&D, with a focused dedication to core technologies in vital signs monitoring.

Starting with the supply of vital signs monitoring modules, the company has forged ahead through continuous innovation and iterative breakthroughs, gradually building a comprehensive product portfolio covering full clinical scenarios including bedside monitoring, patient transport monitoring and respiratory monitoring. Witleaf holds dozens of core technology patents, with its SpO₂ technology certified by authoritative international bodies. It has been recognized as a National High-Tech Enterprise in China and awarded multiple provincial and municipal research grants.

The company has achieved a transformative leap: evolving from providing technical solutions to developing finished medical devices, and expanding from serving the domestic market to establishing a global presence. Throughout its development, Witleaf has stayed true to its core philosophy: "Quality as Our Foundation, Innovation as Our Soul."

Empowering Healthcare Worldwide, Safeguarding Every Life

Backed by our advanced vital signs monitoring technology and comprehensive quality management system, Witleaf’s monitoring devices are now widely used in hospitals, emergency medical transport, community healthcare and home health settings across the globe.

Our reliable, accurate and stable monitors deliver critical clinical data to support clinical diagnosis, intraoperative monitoring, postoperative rehabilitation, and critical care treatment, helping healthcare providers worldwide enhance clinical efficiency and ensure patient safety.

Guided by our mission — "Crafting premium medical devices with dedication, safeguarding lives through innovation, and creating shared value together" — Witleaf will continue to deepen its focus in the medical monitoring market. Going forward, we will keep empowering global healthcare through technological innovation, protect every heartbeat with professional expertise, and contribute to the advancement of human health.