EN ISO13485:2016
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CertificateNo. Q5 107415 0001 Rev. 02 Holder of Certificate: CALTH Inc. #321,54 Changeop-ro, Sujeong-gu Seongnam-si, Gyeonggi-do 13449 REPUBLIC OF KOREA Scope of Certificate: Design, Development, Production andDistribution of In-Vitro Diagnostic Reagents for POCT(Rapid immunochromatographic assay)Production and Distribution of In-Vitro Diagnostic Instruments for POCT(Rapid immunochromatographic assay) The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system, which meets the requirements of the listed standard(s). All applicable requirements of the testing and certification regulation of TUV SUD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:Q5 107415 0001 Rev. 02 Valid from: Valid until: Date, 2023-05-31 Chnst°ph Dicks Head of Certification/Notified Body TUV SUD Product Service GmbH • Certification Body • Ridlerstrafce 65 • 80339 Munich • Germany

CertificateNo. Q5 107415 0001 Rev. 02 Applied Standard(s): EN ISO 13485:2016 Medical devices - Quality management systems -Requirements for regulatory purposes (ISO 13485:2016) Facility(ies): calth Inc. #321,54 Changeop-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do 13449, REPUBLIC OF KOREA Distribution of In-Vitro Diagnostic Reagents for POCT (Rapid immunochromatographic assay) CALTH Inc. #7508, 140, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do 14057, REPUBLIC OF KOREA Design and Development of In-Vitro Diagnostic Reagents for POCT (Rapid immunochromatographic assay) CALTH Inc. #1201~1203,...