Shanghai Liangrun Biomedicine Technology Co,Ltd
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ZERTIFIKAT ™ CERTIFICATE
Certification/Authorization from other Countries
European Union :CE
Registration number : RPS/2656/2020
RIO
CERTIFICATE OF NOTIFICATION
This isto certify that, according to the European Couneil Directive 98/797EC, Riomavix S.L.
performed all notification duties and responsibilities asthe European Authorized Representative:
“MANUFACTURER: Shanghai Liangran Biomedicine Technolgy Co, Lid
ADDRESS: Level 4 Buling 1, No. 271, Gama Road, Pilot Free Trade Zone, Shang, China
“The manufacturer has provided Riomavix S.L. with all the appropriate declaration according
to the European Council Directive 98/79/EC including the Declaration of Conformity
confirming that its in vitro diagnostic medical device, as stipulated here below, is
fulfilling the essential requirements ofthe European Council Diretive 9/79/EC.
IVD Devices: LionRun™ SARS-CoV-2 Antigen Rapid Test Kit
Classification: Others
IVD Devices: Novel coronavirus (SARS-CoV-2) mocleie acid detection kit(LFD method)
Classification: Others
Where the manufacturer affix the CE mark to the device liste they must ensure that all the
«essential requirements of European Council Directive 98/79/EC are met
“The notification of abovementioned device has been completed by the European Authorized
Representative in Spain. The Spain Competent Authority is notified of the manufscture’s