The first certification | Tisted on domestic intelligent liquid nitrogen tank approved products

Recently, the liquid nitrogen storage system (BCT38C) independently developed by Basecare has officially passed the approval of Jiangsu Provincial Drug Administration, becoming the first intelligent liquid nitrogen tank product in China to obtain the registration certificate of medical devices (Suwei Registration 20222221946). The intelligent liquid nitrogen tank is not only a domestic, intelligent instrument and equipment, but also an innovative product combining digital industry and traditional industry. Bekon Medical has developed from a single product to a company with multi-scenario solutions covering PGT laboratory, embryo laboratory, andrology laboratory, cryopreservation room and software laboratory in the field of assisted reproduction, building an integrated platform from detection to storage.

As an important and indispensable technology in the process of assisted reproduction, cryogenic cryopreservation technology has been widely used in the field of assisted reproduction. Based on the huge demand for fertility preservation, currently assisted reproduction centers need to invest a large number of long-term storage resources, which are increasing year by year, including storage containers, storage space, management and maintenance. For a long time, over 90% of China's high-end medical devices have been imported, and the proportion of domestic substitution is low. According to the Medical Device Classification Catalogue issued by the State Medical Products Administration in 2017, medical liquid nitrogen storage tanks need to obtain a Class II medical device registration certificate. With the increasing number of infertility and older women, the demand gap for frozen storage will continue to expand, and the market potential is huge.

Based on the shortcomings of the existing traditional aluminum liquid nitrogen tank which is difficult to store, operate and manage, Basecare has developed the intelligent liquid nitrogen tank BCT series equipped with digital management system. The tank has built-in temperature sensors, a smart lid, a built-in combination lock and GPS. While maintaining the -196°C deep and low temperature storage capacity, BaseStation system can carry out continuous monitoring and real-time warning for the storage temperature and liquid level of samples, realizing the intellectualization, automation and informatization of the sample library, and meeting the staff's requirements for equipment supervision, accurate sample positioning and rapid sorting.

The refrigeration storage room scenario solution is jointly created by Basecare and Haier Biology, a leading domestic cryogenic storage enterprise. Based on the general direction of independent research and development and domestic substitution proposed by the state, the solution focuses on fertility preservation and builds an intelligent refrigeration storage scenario covering the whole temperature range from -196℃ to -86℃, creating a pioneer of intelligent management. It has promoted the comprehensive expansion of the application scenarios related to fertility preservation, and brought hope for many people to meet their reproductive needs and guarantee reproductive health. In May 2023, the construction of Basecare industry base will be completed soon, and the innovative products represented by intelligent liquid nitrogen tank will enter a larger scale of high-quality production. This time, Basecare intelligent liquid nitrogen tank successfully obtained the registration certificate of medical devices, marking an important step of the company in the improvement of frozen storage scenario solutions and commercialization process, which can accelerate the realization of the whole industrial chain layout of assisted reproduction industry in the future and promote industrial upgrading.