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CECERTIFICATENOTIFICATION

www.cmcmedicaldevices.com

CMCMEDICALDEVICES&DRUGSSLC/HoracioLengoNº18,CP29006Málaga-Spain

NO.CMC/CE/2020/17042020-1

CONFIRMEDTHATCMCMEDICALDEVICES&DRUGSS.L.IstheEuropeanAuthorizedRepresentativefor

AnnexIMedicalDeviceProductswith1page

MANUFACTURERBYCOMPANY:

ZephyrBiomedicals–ADivisionofTulipDiagnostics(P)Ltd.PlotNo:M-46/47,PhaseIIIB,VernaIndustrialEstate,Verna,Goa-India

ThecertificateremainsvaliduntiltheexpirationagreementofECREP,manufacturingconditions,thequalitysystemorrelevantlegislationarechanged.Thevalidityisconditionedbypositiveresultsofperiodicsurveillanceaudits.Theproductliabilityrestswiththemanufacturerinaccordancewithapplicabledirectiveandstandard,afterfulfillingoftherelevantEUlegislationrequirements,themanufacturershallaffixrelevantCEmarkingtoallabovementionedmodelsofthemedicaldevice.ThemanufacturerhasprovidedCMCMedicalDevices&DrugsS.L.withalltheappropriatedeclarationsaspertheCouncilDirective98/79/EEC,includingECDeclarationofConformity.TheproductscoveredareinAnnexIof1page.AllIVDothersproductslistwasregisteredinSpanishAgencyofMedicalDevices(AEMPS)withregistrationnumberRPS/531/2020.ThisproductlistisincompliancewiththeCouncilDirective98/79/EECAnnexIII(IVDOthers).ThisregistrationallowstoplacetheCEintheproductsaswellasitscommercializationintheEUandEEATerritory.Issuedon:17/04/2020

AuthorizedSignatoryCMCMedicalDevices&DrugsSL

CECERTIFICATENOTIFICATION

www.cmcmedicaldevices.com

LIST OF ITEMS COVERED BY THIS CERTIFICATE NO. CMC/CE/2020/17042020-1

COVISCREEN DEVICE (RAPID DOUBLE ANTIGEN SCREENING TEST FOR THE DETECTION OF IGM/IGG/IGA ANTIBODIES TO COVID-19 IN HUMAN SERUM/PLASMA/WHOLE BLOOD)

COVICHECK DEVICE (RAPID TEST FOR THE DETECTION OF IGM & IGG ANTIBODIES TO

SARS-COV-2 VIRUS IN HUMAN SERUM/PLASMA/WHOLE BLOOD