BE 4 ° rs - r wi °o od } = < =) rs = 4 wi re) Sa bE < 3 Ss a Ss e o wi rz) oa nl bid ai i 27: Eas ZERTIFIKAT ® CERTIFICATE @ ((Dakks Deutsne Ricredirungstele Dawassidio0 Certificate No. Q6 077224 0007 Rev. 01 Holder of Certificate: Facility(ies): Certification Mark: Scope of Certificate: Applied Standard(s): ‘Suzhou Yaxin Medical Products Co., Ltd. No.12, Zhongta Road, Mudu Town 215101 Suzhou PEOPLE'S REPUBLIC OF CHINA ‘Suzhou Yaxin Medical Products Co., Ltd. No.12, Zhongta Road, Mudu Town, 215101 Suzhou, PEOPLE'S REPUBLIC OF CHINA Production and Distribution of Disposable Nasal ‘Oxygen Cannula, Disposable Suction Connecting Tube, Disposable Urinary Catheter, Disposable Suction Catheter, Disposable Gastric Tube, Disposable Feeding Bag, Disposable Urine Drainage Bag, Disposable Chest Drainage Bottle, Disposable Oxygen Mask EN ISO 13485:2016 Medical devices - Quality management systems ~ Requirements for regulatory purposes (ISO 13485:2016) DIN EN ISO 13486:2016 ‘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). See also notes overleaf. Report No.: Valid from: Date, 2020-03-26 Page 1 of 1 SH1970101 2020-03-26 2023-03-25 COW Christoph Dicks Head of Certiication/Notified Body ‘TOV SUD Product Service GmbH + Certication Body + Ridlerstrae 65 + 80339 Munich Germany