EC REP CERTIFICATE

ECREPCERTIFICATE

www.cmcmedicaldevices.com

CMCMEDICALDEVICES&DRUGSSLNO.CMC/CE/2020/16032021.9

CONFIRMEDTHATCMCMEDICALDEVICES&DRUGSS.L.IstheEuropeanAuthorizedRepresentativeof

WuhanUNscienceBiotechnologyCo.,LtdBuildingB18,2ndPhaseofBiomedicalPark,#858GaoXinRoad,DonghuHi-Tech

Development,Wuhan,Hubei,P.R.China

ThecertificateremainsvaliduntiltheexpirationagreementofECREP,manufacturingconditions,thequalitysystemorrelevantlegislationarechanged.Thevalidityisconditionedbypositiveresultsofperiodicsurveillanceaudits.Theproductliabilityrestswiththemanufacturerinaccordancewithapplicabledirectiveandstandard,afterfulfillingoftherelevantEUlegislationrequirements,themanufacturershallaffixrelevantCEmarkingtoallabovementionedmodelsofthemedicaldevice.Complieswiththeapplicableessentialrequirementsofthecouncildirective98/79/EECinvitrodiagnosticsasamended.TheproductsinAnnexIwasregisteredinSpanishMOHwithnumberRPS/506/2021Issuedon:16/03/2021 Validuntil:09/10/2021

AuthorizedSignatoryCMCMedicalDevices&DrugsSL

ECREPCERTIFICATE

www.cmcmedicaldevices.com

ANNEXIMedicalDeviceProducts

SARS-CoV-2AntigenRapidTestKit

EC REP CERTIFICATE

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