6115119CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
| Ningbo Hitcm Medical Devices Co., Ltd. No.59 Kechuang North Road, Wangchun Industrial Park, Haishu District 315000 Ningbo, Zhejiang China | |
| LINEAR STAPLERS, VIDEO-ASSISTED SURGERY (H020301, Class IIb) | |
| Group of Devices: Powered Articulating Endoscopic Linear Cutter and Reload | Intended Purpose: The Powered Articulating Endoscopic Linear Cutter and Reload are used for transection, resection, and/or creation of anastomoses. The instruments are intended to be used in multiple open or minimally invasive general, thoracic procedures. |