Tianjin second class medical equipment business scope

A, business scope: Class II; 6801 basic surgical instruments, 6802 microsurgical instruments, 6803 surgical instruments, 6804 ophthalmic cell phone instruments, 6805 ear, nose and throat surgical instruments, 6806 stomatology surgical instruments, 6807 thoracic and cardiovascular surgical instruments, 6808 abdominal surgery, 6809 urinary and anorectal surgery, 6809 surgical instruments, and the business scope and mode of operation. 6 business scope and mode of operation according to the "supervision and management of medical devices regulations" (State Council Decree No. 650), "supervision and management of medical devices" (State Food and Drug Administration Decree No. 8) and other relevant laws and regulations, combined with the unit's existing conditions and the actual business needs, I apply for filing of Class II medical device business scope and mode of operation are: a, Business scope: Ⅱ? Scope of business: Class II medical devices for the record. Class II: 6815 injection and puncture instruments, 6820 general diagnostic instruments, 6821 medical electronic instruments and equipment, 6822 medical optical instruments and endoscopic equipment, 6823 medical ultrasound instruments and equipment, 6824 medical laser instruments and equipment, 6825 medical high-frequency instruments and equipment, 6826 physical therapy and rehabilitation equipment, 6827 Chinese medicine devices, 6840 clinical test and analysis instruments (in vitro diagnostic equipment) Analyzing instruments (in vitro diagnostic reagents only?). Class II: 6801, 6802, 6803, 6804, 6805, 6806, 6807, 6808, 6809, 6810, 6812, 6813, 6815, 6816, 6820, 6821, 6822, 6823, 6824, 6825, 6826, 6827, 6828, 6830, 6831, 6832, 6833, 6834, 6840, 6841, 6845, 6854, 6855, 6856, 6857, 6858, 6863, 6864, 6865, 6866, 6870. Business scope and mode of operation According to the "supervision and management of medical devices regulations" (State Council Decree No. 650), "supervision and management of medical equipment business" (State Food and Drug Administration Decree No. 8) and other relevant laws and regulations, combined with the existing conditions of my unit and the actual business needs, I apply for filing of the second class of medical devices and mode of operation, respectively: