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EC REP CERTIFICATE www.cmcmedicaldevices.com CMC MEDICAL DEVICES & DRUGS SL NO. CMC/CE/2020/07052020.17 CONFIRMED THAT CMC MEDICAL DEVICES & DRUGS S.L. Is the European Authorized Representative of Biocomma Limited B1605-B1606, Life Science Park,Shenchengtou Creative factory, Julongshan Rd, Xiuxin Community, Kengzi St, Pingshan Dist, ShenZhen,518118 P.R. China The certificate remains valid until the expiration agreement of EC REP, manufacturing conditions, the quality system or relevant legislation are changed. The validity is conditioned by positive results of periodic surveillance audits. The product liability rests with the manufacturer in accordance with applicable directive and standard, after fulfilling of the relevant EU legislation requirements, the manufacturer shall affix relevant CE marking to all above mentioned models of the medical device. Complies with the applicable essential requirements of the council directive 98/79/EEC on medical devices as amended. The products in Annex I was registered in Spanish MOH with number RPS/707/2020 Issued on: 07/05/2020 Valid until: 06/05/2021 Authorized Signatory CMC Medical Devices & Drugs SL

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Page 1: EC REP CERTIFICATE - Tecil

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

Page 2: EC REP CERTIFICATE - Tecil

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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