中华⼈民共和国医疗器械注册证英⽂版RegisterationCertificateforMedicalDeviceofthePeople’sRepublic ofChinaRegisterationCertificateNo.:ShandongDeviceRegistrati
onApprovalNo.20182100453RegistrantNamexxxxxxxDomicileofRegi strantxxxxxxxAddressofManufacturingSitexxxxxxAgent’Name(“For importedmedicaldevice”)Agent''sResidence(“Forimportedmedical
device”)ProductNamexxxxxModelandSpecificationxxxxxStructure andCompositionxxxxxScopeofapplicationxxxxxxAnnexRegistrationp roducttechnicalrequirement:ShandongDeviceRegistrationApprov
alNo.20182100453OthercontentRemarksOriginalproductclassifica tionaccordingtotheRulesofMedicalDeviceClassification:Cla
ssII:6841MedicallaboratoryandbasicdevicesandinstrumentsA
pprovedby:FoodandDrugAdministrationofShandongApprovedoregister for
n:xxxxDateofexpiry:xxxx(FoodandDrugAdministrationofShand ongSpecialsealforadministrativeauthor
ization)
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