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1、AppendixProductCatalogforClassIIIMedicalDeviceExemptedfromClinicalTestingNo.ProductNameCategoryCodeProductDescription1Punctureneedle6815Itiscomposedofthepunctureneedletubingandtubingbase.Seldingertechniqueisadoptedtoestablishapercutaneousaccessfortheendovasculardevices.Seldinge
2、rtechniqueisoftenreferredtovascularpunctureindigitalsubtractionangiography.2Guidesleeve6815Itiscomposedofcatheterandcatheterbase(optional).Seldingertechniqueisadoptedtoestablishapercutaneousaccessfortheendovasculardevices.Seldingertechniqueisoftenreferredtovascularpunctureindig
3、italsubtractionangiography.3Disposablesterilehypodermicneedle6815Theperformance,structure,composition,purposeandetcareentirelycoveredbyGB15811DisposableSterileHypodermicNeedle,theproductiscomposedofneedlebase,junction,needletubingandprotectioncap,itisusedforintracutaneous,subcu
4、taneous,intramuscular,intravenousinjectionsinthehumanbodyortodrawfluiddrugs.Iftheproductcontainsanyspecialfunctionorstructure(e.g.selfdestruction,prickproofetc),thenitshallnotbeexemptedfromclinicaltesting.Theareaofexemptiondoesnotcoverproductsthatadoptnewmaterial,activeingredie
5、nt,newtechnique,newdesignorproductsthatpresentnewpurpose,mechanismorfunction.4Disposablesterilizedsyringe6815Theperformance,structure,composition,purposeandetcareentirelycoveredbytheGB15810DisposableSterileSyringe,theproductiscomposedofsyringesleeve,plunger,sealingring,corecyli
6、nder,thepushendandtheconeend,itisusedfordrawingliquidorinjectionsbyhandrightafterdrawingliquid.Iftheproductcontainsanyspecialfunctionorstructure(e.g.selfdestruction,prickproofetc),thenitshallnotbeexemptedfromclinicaltesting.Theareaofexemptiondoesnotcoverproductsthatadoptnewmate
7、rial,activeingredient,newtechnique,newdesignorproductsthatpresentnewpurpose,mechanismorfunction.5Disposableintravenousneedle6815Theperformance,structure,composition,purposeandetcareentirelycoveredbytheGB18671DisposableIntravenousNeedle,theproductiscomposedofneedletubing(nominal
8、outerdiameter0.36-1.2mm),needlehandle,flexibletube,con
