bE ey re) i 5 4 rr rc) ¢ ° = = o x e r rv) °o od e es -j Ss & = i o wi ° ° poet ZERTIFIKAT @ CERTIFICATE @ ((Dakxs Sora" Prot Service Certificate No, Q6 061500 0007 Rev. 01 Holder of Certificate: Rayco (Xiamen) Medical Products Company Limited 308 Wengiao Road Haicang District 351022 Xiamen, Fujian PEOPLE'S REPUBLIC OF CHINA ility(ies): Rayco (Xiamen) Medical Products Company Limited Facility(ies) 308 Wengjiao Road, Haicang District, 361022 Xiamen, Fujian, PEOPLE'S REPUBLIC OF CHINA Certification Mark: tween Scope of Certificate: Production of Health Imaging Film Applied Standard(s); _ EN'S0 13485:2016 Mecical devices - Qualty management systems ~ Requirements for regulatory purposes (ISO 13485:2016) DIN EN ISO 13485:2016 ‘The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system (excluding subclause 7.3), 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: ww tuvsud.com/ps-cert?q=cerl:06 061500 0007 Rev. 0+ Report No.: SH2033301 Valid from: 2021-01-01 Valid uni 2023-12-01 if COK ' Date, 2020-11-23 hy Christoph Dicks. Ste OP Head of Certification Notified Body ONG Cn] HOC Page 1 of 1 ‘TOV SUD Product Service GmbH + Certification Body + RidlerstraBe 65 + 80339 Munich » Germany