博九彩票

    Welcome to Shandong Kejiaxun Medical Technology Co., Ltd!

Home >>News >>Industry Inion

Industry Inion

    The state on the sterilization bag sealing machine not as a medical device notice

    From the State Food and Drug Administration website

    Published on April 15, 2005


    Provinces, autonomous regions and municipalities Food and Drug Administration (Drug Administration):


    In order to meet the needs of medical devices around the supervision and management, oral digital observation devices are now 42 categories of products such as the definition of the following notice:


    First, the oral digital observation instrument: for oral observation. As a Class I medical device management.


    Second, the contrast sensitivity test card: for visual function testing, assessment and diagnosis of visual defects. As a Class II medical device management.


    Third, the three-dimensional test card: used to test stereo vision function. As a Class I medical device management.


    4, ophthalmic lens: for auxiliary eye examination, increase the viewing angle. As a Class I medical device management.


    Fifth, the somatic cell therapy medium: as a class III medical device management.


    6, multi-functional shorts: incontinence for the patient care and bed sores prevention. As a Class I medical device management.


    7, microneedle administration patch (no drug): for skin administration. As a Class II medical device management.


    8, penis growth device: for lengthening the penis, correction penis curvature, penile surgery after surgery. As a Class III medical device management.


    Nine, ozone therapy instrument: produce ozone, through the catheter into the rectum or vagina, treatment of vaginitis, vulvitis, cervicitis and gastroenteritis. As a Class II medical device management.


    10, facial jaw bone reshaping machine: for facial jaw plastic surgery. As a Class II medical device management.


    11, fat transplant machine: by the injection machine, liposuction machine, fat purification machine for fat transplantation. As a Class III medical device management.


    12, micro-crystal grinding treatment device: fine crystal particles will be sprayed to the skin at high speed, rapid and gentle exfoliation of the skin stratum corneum, used to improve skin aging, remove superficial scar and acne scars, improve the cuticle, skin wrinkles, Light spots, superficial freckles, narrow pores, remove blackheads and acne, the treatment of eyelid yellow warts, syringoma. As a Class II medical device management.


    Thirteen, multi-wavelength multi-wavelength medical laser: for deep skin wrinkles, improve the pores and blackheads, eliminate hair, tattoo, tattoo, tattoo, tattoo, pigment pigmentation, acne scars, seborrheic skin, Nevus, mole, port wine stain, spider-like telangiectasia. As a Class III medical device management.


    14, high-frequency Doppler ultrasound skin tomography: for the skin 2D, 3D image scanning. As a Class II medical device management.


    15, bone bed cleaning system: used in orthopedic surgery to clean the bone surface of the blood and debris. As a Class II medical device management.


    16, anatomical / Executive grip pliers: with a thorn, for minimally invasive surgery, and endoscopic support for crawling, cutting. As a Class II medical device.


    Seventeen, atomization filter: one-time use, then connected to the tracheal tube, for respiratory filtration, insulation humidification, maintaining smooth airway. As a Class II medical device management.


    18, to avoid snoring spirit: for the nasal cavity and throat to keep the mucous membrane between the humid, reduce snoring when sleeping. If there is no pharmacological effects, as a class II medical device management.


    19, bone cement casing components: for bone cement mixing, transportation. As a Class I medical device management.


    20, biochemical analyzer with reference solution: for testing potassium, sodium, chloride ion potential of the electrolyte solution and polymerization agent. As a Class I medical device management.


    Biochemical analyzer with 7% bovine serum albumin: reaction component of 7% bovine serum albumin, as a dilution for the test results beyond the system linear range of human serum samples. As a Class I medical device management.


    22, biochemical analyzer with a special dilution: the reaction component of human serum, as a dilution for the test results beyond the system linear range of human serum samples. As a Class I medical device management.


    Citric acid solution for biochemical analyzer: It is an aqueous solution of citric acid and a preservative for stabilizing the acid phosphatase component in serum / blood samples. As a Class I medical device management.


    24, biochemical analyzer with the immune rinse: water-soluble matrix solution for the immune rate test. As a Class I medical device management.


    25, biochemical analyzer with a magnetic HDLC reagent: for the sample pretreatment, precipitation of serum / blood in the low-density lipoprotein and very low density lipoprotein, the magnetic removal of precipitated lipoprotein, high-density lipoprotein Of the supernatant. As a Class I medical device management.


    Twenty-six, suture buckle: for surgical suture fixation, suture no longer knotted. As a Class I medical device management.


    Twenty-seven, distilled water machine: for the preparation of distilled water. Not as a medical device management.


    28, sterilization bag sealing machine: for sterilization bags for sealing. Not as a medical device management.


    29, dental phone cleaning and curing machine: for dental cleaning and lubrication of dental care and maintenance. Not as a medical device management.


    30, rotary vane vacuum pump: for sealing the container extraction of air, access to vacuum equipment. Not as a medical device management.


    Thirty-one, electric constant temperature water bath: for evaporation and constant temperature heating. Not as a medical device management.


    32, magnetic stirrer: for solvent agitation. Not as a medical device management.


    Thirty-three, low blood temperature console: used to provide low-temperature blood treatment environment. Not as a medical device management.


    34, the finger clip: for dressing, protect the injured fingers, do not directly contact the wound. Not as a medical device management.


    Thirty-five, medical insulation cabinet: for heating of medical supplies, to set the temperature, so that patients feel comfortable. Not as a medical device management.


    Thirty-six, the human body washing machine: the bed for the patient's body surface, hair for cleaning. Not as a medical device management.


    Thirty-seven, portable temperature control box: can control the temperature of the active portable storage box for food, medicine, biological products, blood, laboratory specimens for storage and transportation. Not as a medical device management.


    38, endoscopic heater: for heating the endoscope, the endoscope to reach a temperature similar to the human body. Not as a medical device management.


    Thirty-nine, endoscopic disinfection box: for endoscopic disinfection of the carrier, and after sterilization storage. Not as a medical device management.


    40, endoscopic cleaning tube: for washing endoscopic tube, instrument channel. Not as a medical device management.


    41, endoscopic cleaning brush: for cleaning endoscopy. Not as a medical device management.


    Forty-two, blood cell analyzer with a cleaning solution: for the instrument pipeline cleaning, intended not as a medical device management.


    Where the above definition of medical device products, from November 1, 2005 implementation of the adjusted category. From the date of issuance, the relevant food and drug supervision and management departments can accept the registration of such products.



    State Food and Drug Administration

    April 15, 2005


     

Contact: Mr. Zhao

Phone: 18605336002

E-mail: sdkejiaxun@126.com

Website:

Address: No. 135, Zhengtong Road, Gaoxin District, Zibo City, Shandong Province

Add the public number

All Rights Reserved ©   Shandong Kejiaxun Medical Technology Co., Ltd

友情链接:幸运彩票官网  盛兴彩票官网  盛世彩票平台  盛兴彩票官网  盛世彩票  盛兴彩票平台  幸运彩票官网  

免责声明: 本站资料及图片来源互联网文章,本网不承担任何由内容信息所引起的争议和法律责任。所有作品版权归原创作者所有,与本站立场无关,如用户分享不慎侵犯了您的权益,请联系我们告知,我们将做删除处理!