6118114CE01
| EU Quality Management System Certificate | |
| Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
| Manufacturer | Yian Medical Technology (Haining) Co., Ltd. 1st Floor Area 1,2nd Floor Area 1, Building A, No. 2 Caohejing Road, Haining Economic Development Zone, Haichang Street, Haining City 314400 Jiaxing City, Zhejiang Province China |
| DIRECT DIGITAL X-RAY SYSTEMS (Z110311, class IIb) | |
| Group of Devices: Digital Mobile Photographic X-ray Machine | Intended Purpose: Mainly used for chest, abdomen, limbs and other parts (spine and pelvis) of X-ray photography examination, image for clinical diagnosis. |