Question two: a class of medical devices. How many kinds of products are included in the household medical equipment in the classification of most of the medical equipment belongs to a class of medical devices, the state control is relatively loose, the application process is also relatively simple, so the feeling is like a general instrumentation, but because it is also an auxiliary means of medical treatment, so it is defined as a medical device. For example, many of the following are:
Home health care equipment Pain *** equipment, home health care self-testing equipment, blood pressure monitors, electronic thermometers, multi-function therapeutic instrument, blood glucose meter, vision improvement equipment, sleep improvement equipment, oral hygiene and health products, adult home health care equipment
Home health care *** products Motorized *** chairs/beds; ***; *** whack; ** pillow; *** cushion; *** cushion; *** chair/bed; *** whack; *** pillow; *** cushion. *** Pillow; *** Cushion; *** Lumbar Belt; Blood and Qi
Circulation Machine; Foot Bath; Foot *** Appliance; Handheld *** Appliance, *** Bathtub, Fat Dumping Belt;
Therapeutic Instrument; Plantar Physiotherapy Instrument; Weight Loss Belt; Car Seat Cushion; Kneading Cushion; *** Chair; Breast Enhancement Appliance;
Cosmetic *** Appliance.
Home Medical Rehabilitation Equipment Therapeutic Instruments, Kaikang High Potential Therapeutic Instrument, Cervical Spine Therapeutic Instrument, Household Cervical Spine and Lumbar Spine Tractor, Traction Chair, Physiotherapy Instruments, Sleep Instruments, *** Instruments, Functional Chairs, Functional Beds, Supports, Medical Inflatable Air Cushions; Oxygen Generator, Decoctions, Hearing Aids, etc.;
Home Nursing Care Equipment Home Rehabilitation Nursing Care Auxiliary Appliances, Women's Pregnant and Infant Nursing Care Products Hello, there are 2 kinds of large-scale medical equipment categorized as a class A and there is a is a class B, medical heron long song large-scale medical equipment is not bad! You can refer to it! The following is a detailed classification of large medical equipment A and B!
Category A:
1. X-ray positron emission tomography (PET-CT, including positron emission tomography that PET).
2. Gamma ray stereotactic treatment system (γ knife).
3. medical electron cyclotron acceleration system (MM50).
4. proton therapy system.
5. Other unit price of 5 million yuan and above, large-scale medical equipment.
Category B:
1. X-ray computed tomography (CT).
2. Medical magnetic **** vibration imaging equipment (MRI).
3. digital subtraction angiography X-ray machine (DSA).
4. medical electronic linear gas pedal (LA).
5. single photon emission computed tomography (SPECT).
Color ultrasound does not belong to category B large medical equipment.
As modern hospitals use higher market value, larger medical equipment, there are CT, nuclear magnetic **** vibration, DR system, CR, frequency X-ray machine, trolley B ultrasound diagnostic instrument, extracorporeal shock wave lithotriptic machine, hyperbaric oxygen chambers, linear gas pedal and so on.
I hope to help you solve the problem!!!!
Question 4: What are the products of medical device class I life contact with cotton swabs, gauze, thermometers, dental materials, electronic computer layer scanning diagnostic devices, disposable hypodermic needles, gauze and condoms are medical devices
Question 5: What are included in the medical devices, what do they do? A class: through routine management is sufficient to ensure its safety, effectiveness of medical devices. Such as most of the surgical instruments, stethoscopes, surgical caps, masks, medical X-ray film, wound post and so on.
Class II: its safety, effectiveness should be controlled medical devices. Such as thermometers, sphygmomanometers, cardiac diagnostic equipment, medical cotton wool, medical gauze, constant temperature incubators.
Class III: potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Such as: implantable cardiac pacemakers, IOLs, single-use sterile syringes or infusion tubes. Need to follow up
Question 6: What are the three types of medical devices Class C devices: 6823 medical ultrasound instruments and related equipment, 6824 medical laser instruments and equipment, 6825 medical high-frequency instruments and equipment, 6826 physical therapy and rehabilitation equipment, 6828 medical magnetic *** vibration equipment, 6830 medical X-ray equipment, 6831 medical X-ray accessory equipment and components, 6832 medical high-energy radiation equipment, 6833 medical nuclide equipment, 6840 clinical laboratory analyzers, 6845 extracorporeal circulation and blood processing equipment, 6854 operating room, emergency room, diagnostic and treatment room equipment and appliances
Ⅲ 6821 medical electronic instruments and equipment, Ⅲ 6822 medical optical appliances, instruments and endoscopic equipment (contact lenses and their care, except for the liquid class), Ⅲ 6846 medical electronic instruments and equipment, Ⅲ 6822 medical optical appliances, instruments and endoscopic equipment (contact lenses and their care except the fluid class) ), Class III 6846 implantable materials and artificial organs, Class III 6877 interventional devices.
Question 7: What are the Class II medical devices included Hello.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software.
Effectiveness is obtained primarily by physical means, not by pharmacological, immunological, or metabolic means, or when such means are involved but only in an ancillary manner.
The purpose is the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the examination of samples from the human body for the purpose of informing medical or diagnostic purposes.
The state implements the classification and management of medical devices according to the degree of risk.
The first category is low-risk medical devices, the implementation of routine management can ensure its safety and effectiveness.
The second category is a moderate risk, need to strictly control the management of medical devices to ensure their safety and effectiveness.
The third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
Examples: cervical spine bite bone forceps, cervical spine bi-articular bite bone forceps, scoliosis correction forceps, nucleus pulposus forceps, vertebral plate bite bone forceps, curved head flat mouth sphenoid bone forceps, gun-shaped bite bone forceps, cerebral neural knife, detachable meningeal knife, cerebral neural knife, meningeal knife, endocardial myocardial biopsy forceps, atrial side wall forceps, aortic sidewall forceps, aortic obstruction forceps, aortic hemostatic forceps, aortic freezing forceps, non-injury pulmonary artery Hemostatic forceps, non-injurious arterial hemostatic forceps, non-injurious arterial catheterization forceps, arterial sidewall forceps, arterial blocking forceps, venous blocking forceps, vena cava forceps, vena cava free forceps, main pulmonary artery forceps and so on
Problem 8: What does a class of medical devices include Class I medical devices refers to the routine management of the foot of the medical device. In general, where the application of the body is not in direct contact with the skin or tissue, the structure is relatively simple, relatively single function, generally passive (external or built-in power supply or other power sources), there is a certain role in assisting or alleviating the symptoms or preventing, the potential risk is very small or virtually no risk, no special management can ensure that its medical devices are more of a class of medical devices; implanted in the body, contact with blood or body fluids The medical devices implanted in the body, in contact with blood or body fluids, external power supply, high power, trauma or radiation and other injuries to the human body, play a major diagnostic, therapeutic or other roles, must be used by specialized or trained personnel to operate or manage in order to ensure its safety, effectiveness, the majority of the potential risk of Class III medical devices; the rest are basically Class II medical devices. The number of Class II devices accounted for 60%, and Class I and III each accounted for about 20%. According to the above principles of judgment, eight or nine. For the classification of specific products attributed to the State Food and Drug Administration website in the "Medical Device Classification Catalog".
Question 9: What are the Class II medical devices? Class II 6866 medical polymer materials and products, Class II 6865 medical suture materials and adhesives, Class II 6864 medical hygiene materials and dressings, Class II 6863 stomatological materials, Class II 6858 medical cold therapy, cryogenic, refrigeration equipment and appliances, Class II 6857 disinfection and sterilization equipment and appliances, Class II 6856 ward care equipment and appliances, Class II 6854 operating room, emergency room, diagnostic and treatment room equipment and appliances, Class II 6854 operating room, first aid room, diagnostic and treatment room equipment and appliances. Class II 6846 implantable materials and artificial organs, Class II 6826 physical therapy and rehabilitation equipment, Class II 6823 medical ultrasound instruments and related equipment, Class II 6822 medical optical instruments, instruments and endoscopic equipment, Class II 6821 medical electronic instruments and equipment, Class II 6820 general diagnostic instruments, Class II 6815 injection and puncture instruments
Question 10: What are the details of Class I, Class II and Class III of medical devices? 5 points You can view the "Classification of Medical Devices Catalog" which contains almost all the medical devices
.