ZERTIFIKAT @ CERTIFICATE @ ioatae@ @ CEPTUOUKAT @ CERTIFICADO @ CERTIFICAT ((Dakks ‘eueche Alicedsieungstelle Dawasn1ei00 Certificate Product Senice No. Q5 064660 0037 Rev. 01 Holder of Certificate: Certification Mark: Scope of Certificate: Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Room 608-611 No. 5 Zhongtai International Plaza No.311Middle of Jiangdong Road Central Business District 210019 Nanjing PEOPLE'S REPUBLIC OF CHINA Design and Development, Production and Distribution of Medical Devices (For detail information see attachement) ‘The Ceriiication 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). See also notes overleaf. Report No.: Valid from: Valid until: Date, 2019-04-23 Page 4 of 2 $H1928716 2019-06-01 2022-05-31 | Poomif Stefan Preif, ‘TUV SUD Product Service GmbH * Certification Body + Ridlerstrafe 65 + 80339 Munich « GermanyiS 7 rm) ms Tie o wi °o ° ° a < °o z ye wi °o ° e 4 3 S aS = e a wi ce) o ad i Eici EF ici ZERTIFIKAT @ CERTIFICATE @ i \( Deutsche ‘Alarederungstlle Dawasietaro0 Certificate No. Q5 064660 0037 Rev. 01 1; EN ISO 13486:2016 Applied Standard(s): jie jco\ devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) DIN EN ISO 13485:2016 Facility(ies): Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Room 608-611, No. 5 Zhongtai International Plaza, 'No.311Middle of Jiangdong Road, Central Business District, 210019 Nanjing, PEOPLE'S REPUBLIC OF CHINA For the product(s)/product category (ies): Design and Development, Production and Distribution of Infant Incubator, Infant Radiant Warmer, Non-Absorbable Surgical Sutures with/without Needles, Blood Bag, Natural Latex Rubber Condom, Alll Silicone Foley Catheter, Tracheostomy Tubes, Urethral Catheter(Latex) Production and Distribution of Medical Tubes and Catheters, Surgical Dressings, Respiratory Ranges, Non-woven Surgical Products, Wound Care Devices & Appliances, Nursing and Surgical Accessories, Blood Band Products, Diagnosis & Observation Equipments, First-Aid Series, Acupuncture, |.V. Flow Regulator for Single Use, Endobronchial Tube, Multi- vent Masks, Endobronchial Blocker Tubes, Wound Drainage System With and Without Trocar, Nasopharyngeal Airways, Pre-filled Syringes, Mercury Free Clinical Thermometer, Sterile Surgical Drapes, Sterile Non Woven Bedsheets, Sterile Non woven Pillowcases, Eye Pad, Sterile Wound Plaster/Strips, Sterile Wound Adhesive Dressings, Infra-red Forehead Thermometers, Medical Electrical Saw Drill, Stethoscope, Zinc Oxide Adhesive Plaster Distribution of Condoms, Surgical Instruments, Homecare and Dental Products, PE/CPE Surgical Products, Clinical Testing Chemistry Reagents & Test Paper, Clinical Testing Devices & Assay Instruments, Medical Optical Devices & Endoscopes, Model Series, Physical Therapy & Convalesce Equipments Page 2 of 2 ‘TOV SUD Product Service GmbH + Certification Body + Ridlerstrafe 65 80339 Munich + Germany