Depends on which class you are operating.
The scope of Class II medical device filing:
Class II: surgical instruments, 6815 injection and puncture instruments, 6820 general diagnostic instruments, 6821 medical electronic instruments and equipment, 6822 medical optics and endoscopic equipment, 6823 medical ultrasound instruments and equipment and related equipment, 6824 medical laser instruments and equipment, 6825 high-frequency instrumentation and equipment for medical use, 6826 Physical Therapy and Rehabilitation Equipment, 6827 Traditional Chinese Medicine Instruments, 6828 Medical Magnetic **** vibration equipment, 6830 Medical X-ray Equipment, 6831 Medical X-ray Accessory Equipment and Components, 6833 Medical Nuclide Equipment, 6834 Medical Radiation Protection Supplies, Devices, 6840 Clinical Test and Analysis Instruments (In Vitro Diagnostic Reagents Limited to Early and Early Pregnancy Detection Paper, Ovulation Paper, Urine Sugar Test Paper, Blood Sugar Test Paper) test strips, blood glucose test strips), 6841 medical laboratory and basic equipment, 6845 extracorporeal circulation and blood processing equipment, 6846 implantable materials and artificial organs, 6854 operating room, emergency room, diagnostic and treatment room equipment and appliances, 6855 stomatology equipment and appliances, 6856 ward care equipment and appliances, 6857 disinfection and sterilization equipment and appliances, 6858 medical cold therapy, cryotherapy, cold storage Equipment and apparatus, 6863 stomatology materials, 6864 medical hygiene materials and dressings, 6865 medical suture materials and adhesives, 6866 medical polymer materials and products, 6870 software? Class II medical device record business scope.
The scope of Class III medical device license is as follows:
6804 Ophthalmic Surgical Instruments; 6807 Thoracic and Cardiovascular Surgical Instruments; 6810 Orthopedic Surgical Instruments (Orthopedics) Surgical Instruments; 6815 Injectable and Puncture Instruments; 6821 Medical Electronic Instrumentation; 6822 Medical Optical Apparatus, Instrumentation and Endoscopic Devices; 6822-1 Medical Optical Apparatus, Instruments and Endoscopic Equipment; 6823 Medical Ultrasound Instruments and Related Equipment; 6824 Medical Laser Instruments and Equipment; 6825 Medical High-Frequency Instruments and Equipment; 6826 Physiotherapy Equipment; 6828 Medical Magnetic **** Vibration Equipment; 6830 Medical X-Ray Equipment; 6831 Medical X-Ray Appurtenances and Components; 6832 Medical High-Energy Radiation Equipment; 6833 Nuclide Equipment for Medical Purposes 6840 Clinical Laboratory and Analytical Instruments (excluding In Vitro Diagnostic Reagents); 6845 Extracorporeal Circulation and Blood Processing Equipment; 6846 Implantable Materials and Artificial Organs; 6854 Operating Rooms, Emergency Rooms, Diagnostic and Treatment Rooms Equipment and Appliances; 6858 Cold Therapy, Cryogenics and Refrigeration Equipment and Appliances for Medical Purposes; 6863 Stomatological Materials; 6865 Suture Materials and Adhesives for Medical Purposes; 6866 Polymers for Medical Purposes materials and products; 6870 software; 6877 interventional devices; 6826 physical therapy and rehabilitation equipment.