Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration), the Medical Devices Technical Committee of Standardization and the focal point:
In order to meet the supervision and management of medical equipment needs, the National Bureau of relevant units and experts in diagnostic medical imaging systems and other products classified defined, is issued to you, please comply with the implementation.
Annex: medical imaging products such as diagnostic classification systems to define
State Food and Drug Administration
On the 13th 20092
Annex:
　　Medical imaging products such as diagnostic classification systems to define
A diagnostic medical imaging systems: in line with the DICOM standard for medical equipment to obtain images, display, storage, image analysis and processing, extraction and reconstruction of three-dimensional images, printing and delivery of software and other functions. Medical devices as Class Ⅲ management. Category Code: 6870.
　　Second, bone marrow, umbilical cord blood stem cell preservation device: from a one-time use sterile pipet, dropper, as well as ultra-low temperature cell preservation tubes for clinical bone marrow, umbilical cord blood stem cell preservation. Medical devices as Class Ⅲ management. Category Code: 6840.
　　Third, Photodynamic Therapy: from head to regulate the devices, power and control system. Photodynamic applications by different wavelengths of light exposure on the organizations for acne, warts, the treatment of vascular disease and certain ancillary histological diagnosis. Medical devices as Class Ⅲ management. Category Code: 6826.
Fourth, the magnetic spin system of adjuvant therapy: from the disk, reducer, motor, treatment beds, glass fiber reinforced plastic shell, composed of computer-controlled systems. Through specific role of magnetic fields on the human body to regulate the body's immune and improve the symptoms and signs of tumor patients as well as reduce or eliminate pain caused by inflammation. Medical devices as Class Ⅲ management. Category Code: 6826.
　　5, protein A immunoadsorption column series solution: by the normal saline solution, citric acid solution, phosphate buffer, composed of sodium azide solution. Immunosorbent assay, respectively, for the pre-red column, elution, balance and storage. Medical devices as Class Ⅲ management. Category Code: 6845.
　　VI antigens of Mycobacterium tuberculosis detection kit (colloidal gold method): The anti-MPB64 monoclonal antibodies and anti-mouse immunoglobulin polyclonal antibody, respectively, in nitrate-coated fiber membrane, at the same time, colloidal gold labeled anti-MPB64 monoclonal antibodies A packet was in the glass fiber membrane, and co-produced with other materials. Application of solid-phase double-antibody sandwich Immunochromatographic analysis, qualitative detection of human sputum, bronchial wash liquid culture medium such as the Mycobacterium tuberculosis secreted protein MPB64, for Mycobacterium tuberculosis anti-bacterial and non-differential. Medical devices as Class Ⅲ management. Category Code: 6840.
　　7, Type A + B rapid diagnosis of influenza A virus Kit (colloidal gold method): The anti-influenza A virus nucleoprotein monoclonal antibody, anti-influenza B virus nucleoprotein monoclonal antibody and anti-mouse immunoglobulin polyclonal antibody , respectively, in nitrate-coated fiber membrane, at the same time, colloidal gold labeled anti-influenza A, influenza B virus, monoclonal antibody-coated glass fiber membrane, and co-produced with other materials. Application of solid-phase double-antibody sandwich Immunochromatographic analysis, qualitative determination of nasal aspiration fluid, nasal fluid and cleaning fluid to clean the throat specimens and influenza A virus antigen, influenza B virus antigens. As a Class Ⅲ
Medical equipment management. Category Code: 6840.
　　8, Type A influenza virus detection kit (colloidal gold method): The anti-influenza A virus nucleoprotein monoclonal antibody and anti-mouse immunoglobulin polyclonal antibody, respectively, in nitrate-coated fiber membrane, at the same time, colloidal gold labeled anti - influenza A virus monoclonal antibody-coated glass fiber membrane, and co-produced with other materials. Application of solid-phase double-antibody sandwich Immunochromatographic analytical techniques, detection of influenza A virus nucleoprotein, of influenza A virus infection for the diagnosis and the aspiration of nasal fluid, nasal fluid and cleaning fluid to clean the throat samples of influenza A virus antigen as Determination. Medical devices as Class Ⅲ management. Category Code: 6840.
　　9, gastroscopy plastic: from the dimethyl silicone oil, poly resin composition of Yamanashi. Enter the body through the throat for gastroscopy with import lubrication, eliminate the role of gastrointestinal bubble. Medical devices as Class Ⅲ management. Category Code: 6866.
　　10, evaporator anesthesia machine: from the base, core, composed of filling devices. The anesthesia machine's auxiliary components, provided the concentration of narcotic controlled steam. Medical devices as Class Ⅲ management. Category Code: 6854.
　　11, positioning plexus: from the host, display, function keys, adjusting knob, connecting tubes, to stimulate the nerve plexus, as well as the annex to the composition of the needle. Difficult position for the deep nerve block, obesity or unclear anatomical landmark positioning the patient's nerve, to guide the needle accurately. Medical devices as Class Ⅲ management. Category Code: 6821.
　　12, argon gas control module: The argon gas pressure relief valve and control module will be of high purity argon gas cylinder high-pressure argon gas into the work of the need for adjustable low-flow argon gas, combined with the high-frequency knife as a knife argon . Medical devices as Class Ⅲ management. Category Code: 6825.
　　13, bleeding microspheres: the main components of the biodegradable cross-linked potato starch. Surface with a microporous, effective absorption of the blood water and low molecular weight substances, and blood platelet, thrombin, etc. gathered in the surface of particles and accelerate the response of endogenous coagulation and promote the body's local hemostasis. Medical devices as Class Ⅲ management. Category Code: 6864.
　　14, pneumatic lithotriptor cavity: from the main tank, control components, gas source of the perfusion pump, operating handle, foot pedal, etc., through the endoscope to the bladder, ureter, kidney stones and other sites as well as open surgery in the stone crushing and effective cavity lavage. Medical devices as Class Ⅲ management. Category Code: 6821.
　　15, male multi-purpose rehabilitation instrument: from the host, control system, the rehabilitation component of negative pressure devices. Negative pressure through the rehabilitation of the equipment devices, directly to the negative pressure suction to the penis to achieve sexual dysfunction for men of the purpose of rehabilitation therapy. Medical devices as Class Ⅲ management. Category Code: 6826.
　　16, photocatalytic teeth whitening agent: The main ingredients of the liquid hydrogen peroxide, nano-titanium dioxide, and methyl cellulose, such as silica. Instrument issued by the White under Blu-ray to accelerate the reduction of hydrogen peroxide to make whitening agents through enamel and dentinal tubules with the teeth of the pigment surface and deep rapid oxidation-reduction reaction resulting to the effect of teeth whitening. Medical devices as Class Ⅲ management. Category Code: 6863.
　　17, thermosensitive poloxamer gel: as the main containing poloxamer 407, propylene glycol, glycerol, hyaluronic acid of the sterile, non-heat the material. Temperature sensitivity, can be quickly and easily in the wound uniformly coated with the human body after the heat exchanger to form a solid gel, which will be wound and separated from other organizations, to effectively prevent occurrence of adhesions. Medical devices as Class Ⅲ management. Category Code: 6864.
　　18, the semiconductor laser power system: The system provides a stable laser, used to stimulate cells in combination with lesions of the photosensitizer to achieve the purpose of adjuvant therapy for tumors. Such as weak lasers, medical devices as Class Ⅱ management; such as high-power laser as the management of medical devices Class Ⅲ. Category Code: 6824.
　　19, Bo penis to help support: the use of nickel titanium memory alloy materials. Its two C-shaped ring with two openings connecting strut of the connected parts of the parcel covered with latex sleeve, so as to avoid the human body when the stent fracture injury. The product sets of patients in the root section of penile erection. After penile erection in order to strengthen the overall stiffness. Erectile dysfunction used to help restore capabilities. Medical devices as Class Ⅱ management. Category Code: 6866.
　　20, vaginal antibacterial gel: from gelatin and formed Isomaltooligosaccharide. After melting of the product in the vaginal wall to form a layer of protective gel membrane. Vaginal wall with the outside world so that the isolation of bacteria, thereby preventing colonization of pathogens to antimicrobial effect. For the prevention of vaginitis. Medical devices as Class Ⅱ management. Category Code: 6866.
　　21, wound repair materials: from SiO2, CaO composition. Wound coverage of the product directly to the promotion of acute and chronic wound repair and healing. Such as that used for the body surface, as a medical device Class Ⅱ management; such as that used for the body, as the management of medical devices Class Ⅲ. Category Code: 6864.
　　22, children's vision therapy Miriam: From the desktop, support, side cabinets, as the telescopic伸拉TEUs, Norma control, eye instrument composed of relaxed ease. Vision for children of early detection, prevention and care. Medical devices as Class Ⅱ management. Category Code: 6821.
　　23, blood dialysis equipment with water: the original water pump, pre-treatment system,精密过滤器, reverse osmosis systems, after the water system. Through the reverse osmosis water to achieve the dialysis water requirements for the provision of dialysis machine dialysis water. Medical devices as Class Ⅱ management. Category Code: 6845.
24, infant oxygen hood: from oxygen tubes, lock sets, adjusting plate, cover, cover body composition. The product with the oxygen source, oxygen flowmeter with oxygen for the infant and child safety. Medical devices as Class Ⅱ management. Category Code: 6856.
　　25, sleep disorders evaluation system: information collected by the body fixed system, data transmission adapter and sleep analysis system. Sleep through the human body during the dynamic information monitoring, collection and data uploaded to the workstation using an integrated analysis system for evaluation of sleep. And sleep therapy equipment used to achieve therapeutic effect on insomnia and effective evaluation of the objective. Medical devices as Class Ⅱ management. Category Code: 6821.
　　26, a one-time use of fibrin glue Configurator: by dispensers, and double-up liquid, frame, three, spray nozzle and the needle component. Is used to configure, mixed fibrin glue group were sprayed to the human body after the wound surface. Medical devices as Class Ⅱ management. Category Code: 6866.
　　27, the diagnosis of neonatal TSH kit (colloidal gold method): for neonatal hypothyroidism screening test. Medical devices as Class Ⅱ management. Category Code: 6840.
　　28, hydrotubation contrast delivery systems: from the display and control circuits, communications connectivity, the composition of injection pump. Remote Control for contrast agent injection, hydrotubation diagnosis and treatment. Medical devices as Class Ⅱ management. Category Code: 6831.
　　29, disposable filter micro-organisms: for the patient to prevent, as atomized particles or droplets carried through the lung volume of pathogenic micro-organisms, the spread of lung function testing equipment. Products and oral contact. Medical devices as Class Ⅱ management. Category Code: 6866.
　　30, endoscopic cleaning workstation (without disinfectant): from the beginning of slot washing, enzyme washing tank, sub tank cleaning, disinfection immersion tank, wash tank at the end of drying the composition of Taiwan. For endoscopic cleaning and disinfection. Medical devices as Class Ⅱ management. Category Code: 6857.
　　31, liquid aerosol: from the nozzle, pump body, such as bottles of body composition. The principle of the use of spray pumps, so that the body of liquid smoke bottle, spraying in the affected area evenly. Medical devices as Class Ⅱ management. Category Code: 6854.
　　32, medical conductive paste: used for ECG, EEG diagnostic tests. Medical devices as Class Ⅱ management. Category Code: 6821.
　　33, a one-time use of vaginal drug delivery devices: from the composition of cartridges and putt. For women the vagina to the medicinal. Medical devices as Class Ⅱ management. Category Code: 6866.
　　34, male sexual function monitor: from the host, the dynamic tension recorder, hands-flow, thermal printers, such as drawings of the male sexual function for the inspection and monitoring. Medical devices as Class Ⅱ management. Category Code: 6821.
　　35, suction head: polypropylene polymer materials made by the one-time product. Can not be normal for maternal childbirth, the fetus will be placed sucker head, the use of suction to birth the fetus. Medical devices as Class Ⅱ management. Category Code: 6812.
　　36, location of intracranial lesions in vitro with scalp: Cyanide small rubber from the top, connected with the vertical and horizontal channel filled with reagent. Convex and convex for the brain below the shallower of the incision site of lesion location. Medical devices as Class Ⅱ management. Category Code: 6866.
　　37, atomizer (not including special fluid): the adoption of electronic equipment will be dedicated solution (sodium hydroxide, sodium carbonate and water) into the air, and thus enter the human respiratory system. In order to achieve the role of the treatment of asthma. Medical devices as Class Ⅱ management. Category Code: 6854.
　　38, medicinal brush: used for drug application. If the product is sterile disposable products, medical devices as Class Ⅱ management; otherwise, as the management of medical equipment class Ⅰ. Category Code: 6854.
　　39, breast compression elastic bandages: from shoulder straps, elastic, polymer particles, such as the composition of thoracic belt. After surgery for breast cancer patients for compression bandaging, skin and chest wall to remove the lacuna between, and thus the prevention of subcutaneous fluid, blood and skin flap necrosis. Medical equipment as a management class Ⅰ. Category Code: 6864.
　　40, snoring sleeping position tuner: back pressure for the body control sensor delay of shock devices. When the body back to the formation of pressure equipment, through the contact switch, oscillator launched the work into it by the back side, so as to achieve to reduce or eliminate snoring function. Not as a medical equipment management.
　　41, needle support stent body: by the supporting frames and directional board composed of needle-type instrument to play a supportive role and show the direction, not as a medical equipment management.
　　42, a one-time use of aspirator tube connected: residue when used to attract the operation to connect to attract tubes and aspirator. Not as a medical equipment management.
　　43, medical anti-infection protective bags: polyvinyl alcohol as the main raw material from. For packaging, re-use to be closed to isolate medical equipment, clothing and other clothing. Not as a medical equipment management.
　　44, biochemical Cup washing machine: automatic biochemical analyzer for the cleaning of the reaction cup. Not as a medical equipment management.
　　45, Belle gauze skin bath: bath immersion of the non-woven gauze liquid skin. Bath for the newborn skin, remove the dirt onto the newborn. Not as a medical equipment management.
　　46, ion balance Miriam health: by the signal of the control of the driver of the power supply as well as energy conversion and transmission parts. The product is broken down into the water anion, acting on the plate through the function of the human body, for health care. Not as a medical equipment management.
　　47, blood filter white cabinets: used to filter out white blood cells of blood to provide a low temperature process. Not as a medical equipment management.
　　48, blood console: for the blood after the blood typing provide a low-temperature operating environment. Not as a medical equipment management.