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Medical Net, July 2nd, in order to implement the "Regulations on the Supervision and Administration of Medical Devices", the State Food and Drug Administration has organized and formulated the "Catalogue of Class II Medical Devices Exempted from Operation and Filing".
See the attachment for specific products
.
It is now announced
.
Attachment: Product Catalogue of Type II Medical Devices Exempted from Operation Record
National Food and Drug Administration June 28, 2021
See the attachment for specific products
.
It is now announced
.
Attachment: Product Catalogue of Type II Medical Devices Exempted from Operation Record
Serial number | product name | product description | use | Directory name |
---|---|---|---|---|
1 | Blood Pressure Monitor | It usually consists of a blocking cuff, a sensor, an air pump, and a measuring circuit . Electronic equipment for blood pressure measurement using oscillometric method, offset sound method or similar non-invasive blood pressure indirect measurement principle . | Used to measure the patient's blood pressure on the arm or wrist . | 07 Medical examination and monitoring equipment |
2 | Mercury sphygmomanometer | It usually consists of a blocking cuff, a stethoscope, and a pressure gauge . A device that uses mercury or mechanical watch display to measure blood pressure using the offset method or similar non-invasive blood pressure indirect measurement principle . | Used to measure the patient's blood pressure on the arm or wrist . | 07 Medical examination and monitoring equipment |
3 | Sterile medical absorbent cotton | Usually includes water-absorbing materials . For ease of use, some products have handheld components . Contains no disinfectants . Provided aseptically, for one-time use . | It is used to clean the skin and wounds . | 14 Infusion, nursing and protective equipment |
4 | Medical skimmed gauze | It is usually a dressing made of medical absorbent cotton gauze or a blended gauze of absorbent cotton and viscose fiber through cutting, folding, packaging, and sterilization . | It is used to absorb the exudate in the body during the operation, and to support the organs and tissues during the operation . | 14 Infusion, nursing and protective equipment |
5 | Absorbent cotton gauze | It is usually a dressing made of medical absorbent cotton gauze or a blended gauze of absorbent cotton and viscose fiber through cutting, folding, packaging, and sterilization . | It is used to absorb the exudate in the body during the operation, and to support the organs and tissues during the operation . | 14 Infusion, nursing and protective equipment |
6 | condom | It is usually made of natural rubber latex or synthetic latex or polyurethane film, and the open end is a sheath with a complete rolled edge . Provided non-sterile . | Used in the local area of the reproductive tract, physical methods (mechanical blocking) are used to prevent sperm from reaching the mouth of the uterus, thereby blocking the encounter between sperm and egg to achieve the purpose of contraception . | 18 Obstetrics and Gynecology, assisted reproduction and contraceptive devices |
7 | Contraceptive cap | It is usually made of natural rubber latex or synthetic latex or polyurethane film, and the open end is a sheath with a complete rolled edge . Provided non-sterile . | Used in the local area of the reproductive tract, physical methods (mechanical blocking) are used to prevent sperm from reaching the mouth of the uterus, thereby blocking the encounter between sperm and egg to achieve the purpose of contraception . | 18 Obstetrics and Gynecology, assisted reproduction and contraceptive devices |
8 | electric wheelchair | Typically by an electric motor, a battery, a control system, wheels, seat, armrest, footrest and so on . It can be operated by the occupant or caregiver, driven by one or more motors, and supported by a seat . Divided into manual steering and power steering . | It is used to compensate patients with mobility impairment and walking function . | 19 Medical rehabilitation equipment |
9 | Manual wheelchair | Typically by the wheel, the seat, armrest, footrest and so on . Driven by the occupant's hand, pedal-driven, or hand-pushed by the caregiver . There are at least three wheels . | It is used to compensate patients with mobility impairment and walking function . | 19 Medical rehabilitation equipment |
10 | Blood glucose analyzer | Typically consists of a host module, power module, the software module . General principles of electrochemistry, optical reflectometry, colorimetry and the like . Does not include blood collection equipment and adapter reagents . | Used in conjunction with adapter reagents for the qualitative and/or quantitative analysis of the analyte in human samples . | 22 clinical testing equipment |
11 | Blood glucose monitoring system for self-test (blood glucose test strips) | | The product is used to quantitatively detect the glucose concentration in fresh capillary whole blood (for example, it can be used for venous blood, arterial blood, and neonatal blood detection can also be described in detail). The detection site can be fingers, palms and upper arms . It is only used to monitor the effect of blood sugar control in diabetic patients, and cannot be used for the diagnosis and screening of diabetes, nor can it be used as a basis for the adjustment of therapeutic drugs . | 6840 in vitro diagnostic reagents |
12 | Human chorionic gonadotropin detection reagent (pregnancy diagnostic test paper) | | The use of double antibody sandwich immune colloidal gold chromatography and other technologies to achieve in vitro qualitative detection of human chorionic gonadotropin in human urine cannot be used for the detection of trophoblastic tumors . | 6840 in vitro diagnostic reagents |
13 | Luteinizing hormone test reagent (ovulation test paper) | | Through qualitative or semi-quantitative detection of the level of luteinizing hormone in the urine of women to predict the time of ovulation, it is used to guide women of childbearing age to choose the best time to conceive or to guide the safe period of contraception . | 6840 in vitro diagnostic reagents |
National Food and Drug Administration June 28, 2021