EC REP CERTIFICATE - Tecil

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ECREPCERTIFICATE

www.cmcmedicaldevices.com

CMCMEDICALDEVICES&DRUGSSLNO.CMC/CE/2020/07052020.17

CONFIRMEDTHATCMCMEDICALDEVICES&DRUGSS.L.IstheEuropeanAuthorizedRepresentativeofBiocommaLimited

B1605-B1606,LifeSciencePark,ShenchengtouCreativefactory,JulongshanRd,XiuxinCommunity,KengziSt,PingshanDist,ShenZhen,518118P.R.China

ThecertificateremainsvaliduntiltheexpirationagreementofECREP,manufacturingconditions,thequalitysystemorrelevantlegislationarechanged.Thevalidityisconditionedbypositiveresultsofperiodicsurveillanceaudits.Theproductliabilityrestswiththemanufacturerinaccordancewithapplicabledirectiveandstandard,afterfulfillingoftherelevantEUlegislationrequirements,themanufacturershallaffixrelevantCEmarkingtoallabovementionedmodelsofthemedicaldevice.

Complieswiththeapplicableessentialrequirementsofthecouncildirective98/79/EEConmedicaldevicesasamended.

TheproductsinAnnexIwasregisteredinSpanishMOHwithnumberRPS/707/2020

Issuedon:07/05/2020 Validuntil:06/05/2021

AuthorizedSignatoryCMCMedicalDevices&DrugsSL

ECREPCERTIFICATE

www.cmcmedicaldevices.com

ANNEXIMedicalDeviceProducts

Product:TransportandpreservationmediumModels:YVJ-E/YVJ-TE/YVJ-TE1/YVJ-TE2/YVJ-TE3/YVJ-TE4/YVJ-TE5/YMJ-E/YMJ-TE/YMJ-TE1/YMJ-TE2/YMJ-TE3/YMJ-TE4/YMJ-TE5/YMJ-TE6/YMJ-TE11/YMJ-TE12 50pcs/box

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