On July 7, 2026, Suzhou Leanstar Electronics Technology Co., Ltd. officially obtained the Medical Device Manufacturing License issued by the Jiangsu Medical Products Administration. The license strengthens Leanstar’s position as a medical device manufacturer in China and supports compliant, stable, and traceable volume production of registered Class II medical devices within the approved scope. For customers and partners, this milestone provides greater confidence in Leanstar’s quality management, production control, inspection, and delivery capabilities.
From Product Registration to Licensed Medical Device Manufacturing
As a high-tech enterprise focused on the R&D and industrialization of flexible micro-nano sensing technologies, Leanstar has steadily expanded its flexible sensing solutions for medical and healthcare applications. The company previously obtained a Class II Medical Device Registration Certificate in China for its independently developed non-contact sleep monitor, model SS110-M2A. The product is designed for use in medical institutions to monitor and record heart rate and respiratory rate during sleep while the patient is at rest in bed. The new Medical Device Manufacturing License completes a key step from product registration to licensed manufacturing, enabling Leanstar to produce registered medical devices under applicable regulatory and quality requirements.
Flexible Sensing Technology for Non-Contact Sleep Monitoring
Flexible sensing technology makes it possible to collect sleep-related signals without requiring users to wear sensors on the body. Leanstar’s non-contact sleep monitoring solution can be integrated into mattresses or bedding, helping deliver a more comfortable and unobtrusive monitoring experience. In approved product configurations and use scenarios, the system can continuously collect heart rate and respiratory rate signals during sleep. This approach creates practical opportunities for medical sleep monitoring and provides a technology foundation for future solutions in elderly care, rehabilitation, and other healthcare settings, subject to the applicable product approvals and intended use.
Reliable Volume Production for Medical and Healthcare Partners
With both product registration and licensed manufacturing capabilities in place, Leanstar is better positioned to deliver consistent quality, production traceability, and reliable batch supply for its registered medical devices. The milestone also provides a stronger foundation for cooperation with medical device companies, healthcare providers, and solution partners seeking flexible sensor and non-contact monitoring technologies. Looking ahead, Leanstar will continue to strengthen regulatory compliance, quality management, and product innovation while developing accessible health-monitoring solutions for the global medical and healthcare market.
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