6129534CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
Manufacturer: | Jiangsu Brightness Medical Devices Co., Ltd. The 3rd floor of Building 3, Building 1 & Building 5-3, No. 66, Hehuan Road, Zhonglou Economic Development Area 213013 Changzhou, Jiangsu China SRN ID.: CN-MF-000019184 |
| device(s) / groups of device(s): | |
| LINEAR STAPLERS FOR VIDEOSURGERY (H020301, class IIb) | |
| Device Name: Disposable Endocutter & Disposable Endocutter Reload | Intended Purpose: The Device is intended for use in abdominal, thoracic, and gynaecologic surgery for resection, transection, and creation of anastomosis. |