> 5 E i 5| z a i | 2 5 a a 5| a a a 5 a 2 i 5 a > 5 P a > 5| Ee > 5 2 5 z 2 i P 2 5 2 2 5 a a 2 5 a > a 5 a > Ss = 4 o ra = i ws o ° i) 2 4 o ra e a wi ° oa es 3 4 Py 2 a e a wi o ° Bohicgd ZERTIFIKAT @ CERTIFICATE @ Produ: Sevice EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex I! excluding (4) (Devices in Class lla, IIb or Il) No. G1 032913 0043 Rev. 00 Manufacturer: Ningbo David Medical Device Co., Ltd. No.2, Keyuan Road ‘Shipu Science and Technology Park, Xiangshan 315731 Ningbo, Zhejiang Province PEOPLE'S REPUBLIC OF CHINA Product Category(ies): Infant incubator, Transport Incubator, Infant Radiant Warmer, Neonate Bilirubin Phototherapy Equipment, Infant T-piece Resuscitator, Medical Air/Oxygen Blender, Medical Air Compressor, Patient Monitor, Transcutaneous Jaundice Detector ‘The Certification Body of TUV SUD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for design, manufacture and final inspection of the respective devices / device categories in accordance with MDD Annex Il ‘This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance. For marketing of class Ill devices an additional Annex Il (4) certificate is ‘mandatory. All applicable requirements of the testing and certification regulation of TUV SUD Group have to be complied with. For details and cerificate validity see: www tuvsud.com/ps.cert7q=cert.Gt 032913 0043 Rev. 00 Report No. ‘sH2001102 Valid from: 2021-03-23, Valid until 2024-05-26 Date, 2021-03-23 C © Christoph Dicks Head of Certifcation/Notified Body Page 1 of 1 TUV SUD Product Service GmbH is Notified Body with identification no, 0123 TUV SUD Product Service GmbH + Certification Body + Ridlerstrae 65 + 80338 Munich + Germany