MLG Medical Instrument (ShenZhen) Co., Ltd.

Product

Current Location Home -> About MLG -> News

SFDA notice dentistry products such as digital camera system as defined in the classification

Time：【2007-9-22】 Total access【】Secondary 【Print this page】【Return】

2010 Twenty-eighth International Dental Exhibition in Sao Paulo, Brazil January 30, 2010 to February 3, 2010 , held in Sao Paulo, Brazil than in Ann Exhibition Centre . Provinces, autonomous regions and municipalities Food and Drug Administration ( Drug Administration ) :
To meet the needs of the country for the supervision and management of medical devices , now Uterine Balloon therapy device and other product categories defined notified as follows:
First, Uterine Balloon therapy device : for the treatment of dysfunctional uterine bleeding women polycythemia . Water was injected into the balloon 87 of the balloon constant . Some pressure balloon affixed to the wall lining of the uterus , resulting in the occurrence of endometrial tissue necrosis and shedding layers . As Ⅲ class medical equipment management .
Second, the intragastric balloon : the ball ( capsule ) body sheath , catheter , filling tube. The main material is poly dimethyl silicone , polypropylene, and 304 stainless steel. Placed inside the body to help obese people lose weight. As Ⅲ class medical equipment management .
Third, the gastric band system: band , connector , 16g blunt needle , fill port , 22g blunt needle filled stylet metric tubes . The main material for the medical silicone and 304 stainless steel. Implanted in the body , bound in the stomach outside to help obese people lose weight. As Ⅲ class medical equipment management .
Fourth, microcrystalline wear scar beauty instrument : used to reduce surgical scars , scar , burns , growth lines , stretch marks , skin proliferative tumors, severe skin keratinocytes , large pores disease, melasma, pimples , blackheads , pigmentation sunshine harm skin, acne scars, acne scars , superficial scars. Nano- particles using crystal suction γ -ray radiation sterilized , formed under vacuum at 0.08Mpa adjustable jet bombardment damaged skin on the patient and reduce scarring. As Ⅲ class medical equipment management .
Fifth, the cavity stent delivery : for the stent to the lesion cavity . As Ⅲ class medical equipment management .
Six , cerebral blood flow monitoring system: computers, monitors, detector unit , counter unit , software systems, isolated power supply and other components. For measuring the suction head of the patient 133Xe isotope release photons r , and r photon counts . By measuring the value in the computer modeling based on the principle Obrist reconstruct cerebral blood flow images. As Ⅱ class medical equipment management .
Seven, the computer automatically cytology screening system: ADS -chip processor workstations and composed by cable connection between the two. Smear smear screening for squamous carcinoma , adenocarcinoma cell smears and precancerous cell morphology of these two under . As Ⅱ class medical equipment management .
Eight , dental gold deposition solution : The product is a liquid , to prepare PFM crown of pure gold by electrodeposition process . As Ⅱ class medical equipment management .
Nine, Chinese speed control ( unmedicated ) : the controller , body treatment , wetting liquid ( available saline instead ) composition, as a drug therapy vectors . As Ⅱ class medical equipment management .
Ten, visible abdominal cavity expansion : for minimally invasive laparoscopic surgery before establishing a surgical operation required space in the middle of the peritoneal cavity and outside the surgical site . The tube body , the expansion sac , seat tube, seals , three -way injection valve ( seat ) , import column , ending stream clip and protective cap components. As Ⅱ class medical equipment management .
XI, remote monitoring systems : for doctors and implantable cardioverter defibrillator patients in remote detection system interaction and real-time data . Doctors use the system to receive and display patient information collected , the patient remote diagnostics. As Ⅱ class medical equipment management .
XII body balance measuring instrument : for human figure balancing posture and body center of gravity test . As Ⅱ class medical equipment management .
Thirteen , LS- raising eyepiece : 18 years of age for children myopia, myopic astigmatism , farsightedness , hyperopia, astigmatism and mixed astigmatism , amblyopia , strabismus treatment. The glasses, the spectral film , A film refractive errors , raising mesh belt, light source components. As Ⅱ class medical equipment management .
XIV, single-use vessels continuation of oppression : made inflatable balloon for vascular interventional catheter after surgery fixed the puncture site bleeding , put pressure on the blood vessels to stop bleeding continues . Product from the expandable balloon , piping , seat tube, and the adhesive paste composition of the check valve . As Ⅱ class medical equipment management .
Fifteen , plug plug: cardioverter defibrillator accessories. Into IS-1, DF-1 in two models, for clogging excess pacing jack , to form a complete insulator. As Ⅱ class medical equipment management .
Sixteen , silicone lubricant : cardioverter defibrillator accessories. Apply to the need for lubrication of parts , played lubrication. As Ⅱ class medical equipment management .
XVII film of liquid based cytology smear collection components : fluid collected by the cell , cervical sampler , quantitative straws, anti-off slides components. Acquisition and pre-processing for the early diagnosis of cervical samples . As Ⅱ class medical equipment management .
Eighteen , sheepskin bedsore pad : for the prevention of pressure ulcers, bedsores and play the role of adjuvant therapy has produced . As Ⅱ class medical equipment management .
Nineteen total sialic acid kit : for the determination of human sialic acid content . As Ⅱ class medical equipment management .
Twenty , retention fibers : component is polyethylene terephthalate . Is fixed by an adhesive to the tooth surface . For oral dental retainers , including loose tooth retention , temporary repair defects remain , temporary or permanent bridge repair . As Ⅱ class medical equipment management .
Twenty-one, plastic stick swab , rod swab , paper stick swabs : for the throat , mouth, and internal and external cervical , vaginal and skin wounds, urinary tract and nasopharynx , ear and eye , nose and pediatric patients throat , ear and eye for sampling . As Ⅱ class medical equipment management .
XXII, pressurized bleeding bra : breast augmentation surgery for medical pressurized surgery to stop bleeding, do not touch the blood . As a Class Ⅰ medical equipment management .
Twenty-three, home medical breast prosthesis widened entrance control: reusable surgical instruments. Breast augmentation cosmetic surgery for medical prosthesis implantation surgery. When placed in the prosthesis , the product from skin incision to insert , expand curled cylinder, so that the prosthesis from the cylinder into the cavities . As a Class Ⅰ medical equipment management .
XXIV temporary crown molding materials : Preparation crown mold. As a Class I medical device management.
XXV, Gum Protection line : Before the preparation of porcelain teeth , placed on the edge of the gums to avoid dental bur preparation process damage the gums . After completion of the preparation of porcelain teeth removed . As a Class Ⅰ medical equipment management .
XXVI, aspirator tube: disposable utensils, saliva in the mouth for sucking , suction devices used in conjunction with dental units . As a Class Ⅰ medical equipment management .
Xxvii, versatile bra : the bra sets, air bags, belt around the chest pressure components. Augmentation prosthesis for implantation or Boobs ( partial ) reduced after surgery , the bra through the airbag inflator , oppression chest bleeding. Continued use of 10 days to two weeks or longer , do not touch the blood . As a Class Ⅰ medical equipment management .
Xxviii, dentistry digital camera system : medical devices used to capture patient external contour dental condition , comparing before and after treatment as dental records, X -ray film does not have the function . Not as a diagnosis. Not as a medical device management.
Twenty-nine , thermal disinfection device: hemodialysis for piping hot water treatment equipment sterilization . Not as a medical device management.
Thirty, disinfection sheath: polyethylene plastic film , one-time use for laparoscopic guided beam protection. Not as a medical device management.
XXXI, three-dimensional imaging software : the two-dimensional fetal ultrasound equipment generates two-dimensional images into three-dimensional images for pregnant women to watch , and to generate three-dimensional images to edit , store, print , burn CDs , not as a diagnostic purpose. Not as a medical device management.
XXXII, lighting flashlight : observation of patients for eye doctors , the lighting used when the throat . Uses ordinary AA batteries and light bulbs . Not as a medical device management.