e 4 J ra = J rr] <} ad ° i=} 4 <) rs Ee J wi o Bd i 4 = cy 2 bY - or irr) i=} Bd Ta skid eA ey ZERTIFIKAT @ CERTIFICATE @ (( Dakks te sieciteanesete encarta Certificate No. Q6 002145 0002 Rev. 00 Holder of Certificate: Shenzhen IMDK Medical Technology CO., Ltd C Zone, 10F, Building 16 ‘Yuanshan Industrial B Area Gongming Street Guangming District 518106 Shenzhen PEOPLE'S REPUBLIC OF CHINA ‘Shenzhen IMDK Medical Technology CO., Ltd C Zone, 10F, Building 16, Yuanshan Industrial B Area, Gongming Street, Guangming District, 518108 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Certification Mark: cate: Production and Distribution of Pulse Oximeter, Ultrasonic Doppler Fetal Heart Rate Detector i J; ENISO 13485:2016 Applied Standard(s): Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) DIN EN ISO 13485:2016 Scope of Cer ‘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). See also notes overleaf. Report No. 6Z1828301 Valid from: 2018-09-25 Valid until 2021-09-24 Date, 2018-09-25 Stefan Prei Page 1 of 1 ° TUV SUD Product Service GmbH + Certification Body + Ridlerstrate 65 + 80339 Munich + Germany Tov