6115119CE01

EU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III
Manufacturer:
Ningbo Hitcm Medical Devices Co., Ltd. No.59 Kechuang North Road, Wangchun Industrial Park, Haishu District 315000 Ningbo, Zhejiang China SRN ID.: CN-MF-000018667
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.