As a second-class medical instrument, it is managed by passive endoscopic surgical instruments, and the classification code is 6822. Suction/irrigation instrument for endoscopic surgery, classification code 6822. Endoscopic camera system, classification code 6822. Endoscopic cleaning, disinfection and sterilization equipment (if the equipment only has cleaning function, it will be managed as a class I medical device. Classification code 6857. Active endoscopic surgical instruments (such as connecting high-frequency generators or other third-class equipment, shall be managed according to the third-class medical instruments, and other products shall be managed according to the first-class medical instruments. ) classification code 6822. ?
Those that are not managed as medical devices are: endoscope cleaning brush, endoscope disinfection box, endoscope fixer, bracket (belonging to the accessories of endoscope, not managed as medical devices alone) and endoscope heater.
According to the regulations of the US Food and Drug Administration, the endoscope disinfection box is not a medical device. If there is no intellectual property problem, it can be produced.