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State Food and Drug Administration medical imaging diagnosis of a clear classification system to define
February 20, 2009 Releases



In order to meet the supervision and management of medical equipment needs, the State Food and Drug Administration and experts in the relevant organizations of the medical imaging diagnostic systems and other products classified defined, which was recently released.
Class Ⅲ as the management of medical equipment are:
Diagnostic medical imaging systems, bone marrow, umbilical cord blood stem cell preservation, and photodynamic therapy device, the magnetic spin system of adjuvant therapy, protein A immunoadsorption column series solution, Mycobacterium tuberculosis antigen detection kit (colloidal gold method), Type A + B Rapid diagnosis of influenza A virus Kit (colloidal gold method), Type A influenza virus detection kit (colloidal gold method), endoscopic plastic, anesthesia machine evaporator, positioning plexus, argon gas control module, micro-bleeding ball, pneumatic lithotriptor cavity, multi-functional rehabilitation treatment for men Miriam, photocatalytic teeth whitening agent, thermosensitive poloxamer gel, the semiconductor laser power systems.
Class Ⅱ as the management of medical equipment are:
Bo to help support the penis, vagina antibacterial gel, skin wound repair materials, children's vision therapy device, hemodialysis equipment with water, sleep disorders evaluation system, a one-time allocation of the use of fibrin glue, and the diagnosis of neonatal TSH kit ( colloidal gold method), drug delivery systems hydrotubation contrast, a one-time microbial filter cleaning endoscopic workstations (without disinfectant), liquid spray, medical conductive paste, one-time use of vaginal delivery, and male sexual function monitor, fetal first aspirator, atomizer (not including special liquid), medicinal brush.
Medical devices as Class Ⅰ management are:
Breast elastic compression bandage.
Not as a medical equipment management are as follows:
Snoring sleeping position regulator, needle body support frame, one-time use to connect aspirator tube, medical anti-infection protective bag, biochemical Cup washing machine, bath Belle skin gauze, ion balance health device, blood filter white cabinets, console blood .


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