体外诊断医疗器械指令 IVDD 98_79_ec 下的CE认证欧盟公告机构(认证机构)名单,地址和授

NationalStandardsAuthorityofIreland(NSAI)1SwiftSquare,Northwood,SantryDublin9Ireland0050Devicesforself-testingECdeclarationofconformityFullqualityassurancesystemProductionqualityassuranceAnnexIIIAnnexIVAnnexVIIProductsreferredinAnnexII,listAProductsreferredinAnnexII,listBFullqualityassurancesystemProductionqualityassuranceAnnexIVAnnexVIIBSIKitemarkHouse,MaylandsAvenue,HemelHempstead,HertfordshireHP24SQUnitedKingdom0086*IVD0100-Reagentsandreagentproducts,includingrelatedcalibratorsandcontrolmaterials,fordeterminingthefollowingbloodgroups-*IVD0101-ABOsystem-*IVD0102-Rhesus(C,c,D,E,e)-*IVD0103-Anti-Kell*IVD0200-Reagentsandreagentproducts,includingrelatedcalibratorsandcontrolmaterials,forthedetection,confirmationandquantificationinhumanspecimensofmarkersof-*IVD0201-HIVinfection(HIV1and2)-*IVD0202-HTLVIandII-*IVD0203-HepatitisB,CandDFullqualityassurancesystemECtype-examinationProductionqualityassuranceAnnexIVAnnexVAnnexVII*IVD0300-Reagents,reagentproductsanddevicesforself-diagnosis,includingrelatedcalibratorsandcontrolmaterials,fordetermining,detection,quantification,diagnosing,evaluatingFullqualityassurancesystemECtype-examinationECverificationAnnexIVAnnexVAnnexVIAnnexVIICreationDate:08/10/2010LISTOFBODIESNOTIFIEDUNDERDIRECTIVE:98/79/ECInvitrodiagnosticmedicaldevicesNameandaddressofthenotifiedbodiesIDResponsibleforthefollowingproducts/HorizontaltechnicalcompetenceResponsibleforthefollowingproceduresormodulesAnnexesorarticlesofthedirectivesLimitations(Englishonly)1/30*IVD0301-Anti-Duffyandanti-Kidd-*IVD0302-Irregularanti-erythrocyticantibodies-*IVD0303-Congenitalinfections:rubella,toxoplasmosis-*IVD0304-Hereditarydisease:phenylketonuria-*IVD0305-Humaninfections:cytomegalovirus,chlamydia-*IVD0306-HLAtissuegroups:DR,A,BProductionqualityassurance*IVD0300-Reagents,reagentproductsanddevicesforself-diagnosis,includingrelatedcalibratorsandcontrolmaterials,fordetermining,detection,quantification,diagnosing,evaluating-*IVD0307-Tumoralmarker:PSAFullqualityassurancesystemProductionqualityassuranceAnnexIVAnnexVII*IVD0300-Reagents,reagentproductsanddevicesforself-diagnosis,includingrelatedcalibratorsandcontrolmaterials,fordetermining,detection,quantification,diagnosing,evaluating-*IVD0308-Riskoftrisomy21(incl.software)-*IVD0309-Deviceforself-diagnosis:deviceforthemeasurementofbloodsugarFullqualityassurancesystemECtype-examinationECverificationProductionqualityassuranceAnnexIVAnnexVAnnexVIAnnexVII*IVD0400-Devicesforself-testing-*IVD0401-Clinicalchemistry-*IVD0402-Haematology-*IVD0403-Immunology-*IVD0405-Pregnancyandovulation-*IVD0406-SpecimenreceptaclesECdeclarationofconformityFullqualityassurancesystemECtype-examinationECverificationProductionqualityAnnexIIIAnnexIVAnnexVAnnexVIAnnexVIICreationDate:08/10/2010LISTOFBODIESNOTIFIEDUNDERDIRECTIVE:98/79/ECInvitrodiagnosticmedicaldevicesNameandaddressofthenotifiedbodiesIDResponsibleforthefollowingproducts/HorizontaltechnicalcompetenceResponsibleforthefollowingproceduresormodulesAnnexesorarticlesofthedirectivesLimitations(Englishonly)2/30*MDS7206-IVDsinsterilecondition*MDS7208-IVDsutilisingnanomaterials*MDS7209-IVDsutilisingbiologicalactivecoatingand/ormaterial*MDS7210-IVDsutilisingmaterialofhumanoriginLLOYD'SREGISTERQUALITYASSURANCELTD(0088)HiramfordMiddlemarchOfficeVillageSiskinDriveCoventryCV34FJUnitedKingdom0088*IVD0100-Reagentsandreagentproducts,includingrelatedcalibratorsandcontrolmaterials,fordeterminingthefollowingbloodgroups-*IVD0101-ABOsystem-*IVD0102-Rhesus(C,c,D,E,e)-*IVD0103-Anti-Kell*IVD0200-Reagentsandreagentproducts,includingrelatedcalibratorsandcontrolmaterials,forthedetection,confirmationandquantificationinhumanspecimensofmarkersof-*IVD0201-HIVinfection(HIV1and2)-*IVD0202-HTLVIandII-*IVD0203-HepatitisB,CandD*IVD0300-Reagents,reagentproductsanddevicesforself-diagnosis,includingrelatedcalibratorsandcontrolmaterials,fordetermining,detection,quantification,diagnosing,evaluating-*IVD0301-Anti-Duffyandanti-Kidd-*IVD0302-Irregularanti-erythrocyticantibodies-*IVD0303-Congenitalinfections:rubella,toxoplasmosisFullqualityassurancesystemProductionqualityassuranceAnnexIVAnnexVIICreationDate:08/10/2010LISTOFBODIESNOTIFIEDUNDERDIRECTIVE:98/79/ECInvitrodiagnosticmedicaldevicesNameandaddressofthenotifiedbodiesIDResponsibleforthefollowingproducts/HorizontaltechnicalcompetenceResponsibleforthefollowingproceduresormodulesAnnexesorarticlesofthedirectivesLimitations(Englishonly)3/30*IVD0304-Hereditarydisease:phenylketonuria-*IVD0305-Humaninfections:cytomegalovirus,chlamydia-*IVD0306-HLAtissuegroups:DR,A,B-*IVD0307-Tumoralmarker:PSA-*IVD0308-Riskoftrisomy21(incl.software)-*IVD0309-Deviceforself-diagnosis:deviceforthemeasurementofbloodsugar*IVD0400-Devicesforself-testing-*IVD0401-Clinicalchemistry-*IVD0402-Haematology-*IVD0403-Immunology-*IVD0404-Molecularbiology-*IVD0405-Pregnancyandovulation-*IVD0406-SpecimenreceptaclesECdeclarationofconformityFullqualityassurancesystemProductionqualityassuranceAnnexIIIA