Management System Certification Body No. MSCB-105 CERTIFICATE No. 23-B-1587 Rev. 0 GeneCker Co., Ltd. #1006,1007, HausD SeJong Tower, 26, Seongsuii-ro 10-gil, Seongdong-gu, Seoul 04793 REPUBLIC OF KOREA has documented and implemented system in compliance with the requirements of ISO 13485:2016Medical Devices Quality Management System for Development, Manufacture and Sales of molecular diagnostic reagent for In Vitro Diagnostics Use. Technical Area: C: In Vitro Diagnostic Medical Devices (IVD) - Reagents and reagent products, calibrators and control materials for Genetic Testing The certificate is issued on the basis of the results mentioned in the pertinent audit report. Validity of the certificate is conditionally limited by positive results of surveillance audits, which the certified company is committed to undergo. This certificate can be invalid if the certificate holder does not fulfill the conditions set out in the certification agreement. I Institute of Global Certification IAS Initial issue date: Apr. 11. 2023 Head of Certification Body Rm. 501, Daeryung techno town, 638, Seobusaet-gil, Geumcheon-gu, Seoul, Republic of Korea www.igcert.org
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