On July 21st and September 22nd, Ezisurg Medical successively obtained the medical device registration certificates issued by the Shanghai Food and Drug Administration of its two strategically innovative medical device products: easyUSTM ReUse ultrasonic scalpel and easyUSTM disposable ultrasonic scalpel.
Among them, easyUSTM ReUse ultrasonic scalpel has obtained the EU CE certification and the registration certificate issued by Hunan Food and Drug Administration in April this year, and has also obtained Chinese invention patent.
easyUSTM ReUse ultrasonic scalpel
easyUSTM ReUse ultrasonic scalpel is mainly used for the auxiliary operation of ultrasonic high-frequency cutting and coagulation in surgery. Relying on the R&D technology accumulation and performance advantages of the previous generation, Ezisurg Medical has creatively transformed disposable high-value consumables into reusable medical devices after a five-year R&D circle, which has prolonged the service life of ultrasonic scalpels, greatly reduced the cost of surgery, and made contributions of “higher value of health economics.” In addition, easyUSTM ReUse ultrasonic scalpel has eliminated the risk of cross-infection in the hospital and improved the use safety. Also, during the surgery, the scalpel can ensure that the ultrasonic scalpel system is always in a good operation state, so as to make the surgery safer and smoother. In the process of producing the product, Ezisurg Medical carried out two rounds of comprehensive and systematic design validation activities to strictly verify the effectiveness and resistance of device re-sterilization for the finished product and the product after the maximum number of reprocessing. It is proved that the product features good clinical cutting and hemostatic effects and can be safely reused. Besides, Ezisurg Medical has a comprehensive quality management system to guarantee a relatively high yield rate, which makes the company takes more benefit in cost control.
easyUSTM disposable ultrasonic scalpel
easyUSTM disposable ultrasonic scalpel, the other strategic product of Ezisurg Medical, has completed systematic design validation activities, including type testing, animal testing, shelf verification, and packaging verification in the process of product realization.
Referring to the usage habits of clinicians, Ezisurg Medical designed the easyUSTM disposable ultrasonic scalpel to be more in line with the operating habits of Chinese doctors, and can be used with the generator and handpiece of the easyUSTM Ultrasonic Scalpel System.
An innovative design is adopted in the waveguide of the easyUSTM, which can simultaneously maximize the cutting speed and coagulation effect, and has been applied for an invention patent. Meanwhile, Ezisurg Medical has reduced the cost through reasonable design, so that more patients can use disposable ultrasonic scalpels at a lower price.
The mission of Ezisurg Medical is to materialize technological innovation, deliver quality products, and build a high-end Chinese brand renowned internationally.
Ezisurg Medical focuses on the revolution that bears great clinical value and benefits in the health economy. Committed to providing better medical technologies, products, and services for doctors and patients worldwide, Ezisurg Medical offers solutions to governments as well as commercial and public institutions in many countries.