Becan Medical Secures China's First Medical Device Registration Certificate for Intelligent Liquid Nitrogen Tank

On November 8, 2022, Beikang Medical’s independently developed liquid nitrogen storage system, the BCT38C, received medical device registration approval, becoming the first intelligent liquid nitrogen tank product in China to obtain a medical device registration certificate. Liquid nitrogen tanks provide an ultra-low temperature environment of -196°C for sperm, oocytes, and embryos, serving as essential equipment for fertility preservation. According to the “Announcement of the National Medical Products Administration on Issuing the Medical Device Classification Catalog (No. 104 of 2017)” issued by the National Medical Products Administration (NMPA) in 2017, medical liquid nitrogen storage systems are explicitly classified as Class II medical devices. Currently, there is a lack of high-quality liquid nitrogen tank products with medical device registration certificates in the industry, and many reproductive centers still use imported liquid nitrogen tanks without such certification. The approval of Beikang Medical’s liquid nitrogen storage system fills the gap in domestically produced intelligent storage equipment in the field of fertility preservation.

This device features an intelligent lid equipped with a digital management system. Multiple temperature sensors are fixed inside the tank to display and monitor internal temperatures in real time, enabling networked management. The lid also incorporates a combination lock that supports dual-person verification for unlocking and automatically records operation logs. While ensuring ultra-low temperature storage at -196°C, the system provides continuous monitoring and real-time alerts for sample storage temperatures and equipment operating status, thereby reducing maintenance labor and achieving informatized management. When used in conjunction with the BaseStation management software, it further enables precise location tracking, verification, and rapid retrieval of samples.

In addition to the BCT38C liquid nitrogen storage system, Beikang Medical offers the BSG800, a large-scale automated embryo storage device designed for medium-to-large reproductive centers. Capable of storing 30,000 to 50,000 embryos, the BSG800 achieves full automation in embryo retrieval and liquid nitrogen replenishment. The temperature within the automated tube-picking chamber is maintained below -130°C, and when paired with customized cryogenic transport canisters, it provides comprehensive deep-cryogenic protection throughout the entire process, thereby avoiding repeated freeze-thaw cycles. Each cryovial is integrated with a QR code, enabling automatic scanning and entry of embryo information. Coupled with an exclusively customized intelligent management system, this solution completely liberates embryology laboratory personnel from manual tasks and administrative burdens. While significantly improving work efficiency, it also establishes multiple safeguards to ensure the security of fertility preservation. Currently, Beikang Medical has collaborated with Chongqing Health Center for Women and Children to establish China’s first “Clinical Model Laboratory for Intelligent Embryo Storage,” and with CITIC-Xiangya Hospital of Reproduction & Genetics to establish China’s first “Clinical Model Laboratory for Intelligent Sperm Storage.”

The volume of cryopreserved samples in reproductive centers has been increasing year by year, with storage pressure gradually approaching critical levels. These centers face challenges such as limited space, lack of monitoring for cryostorage equipment, time-consuming and labor-intensive maintenance of liquid nitrogen tanks, and insufficient digitalization of sample records. To address the current difficulties in fertility preservation, Basecare Medical has partnered with Haier Biomedical to deploy equipment including -86°C ultra-low temperature freezers, medical refrigerators, and portable deep-cold transport containers, thereby establishing an intelligent cryostorage scenario covering the full temperature range from 4°C to -196°C. Leveraging the “BaseStation” Internet of Things (IoT) platform, this solution connects scenarios spanning sample collection, storage, and application, enabling cloud-network synergy, precise sample localization, one-click access and retrieval, and information traceability, thus constructing a new system for sample preservation and protection.

Currently, China's medical device industry has been affected by the pandemic, with disruptions to the supply chain for imported equipment. Beikang Medical focuses on the domestic substitution of high-end medical devices. Its completed 70,000-square-meter production base will be dedicated to the large-scale manufacturing of domestically produced instruments. The production workshops feature fully automated assembly lines, with an estimated annual output of 30,000 liquid nitrogen tanks. This capacity is expected to meet domestic clinical demands and promote the standardization, automation, and intelligent upgrading of laboratory equipment.