6115270CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
| Manufacturer | Sinolinks Medical Innovation, Inc No.10 Ziwei Road, Zhonglou Zone Changzhou 213023 Jiangsu China SRN ID.: CN-MF-000010840 |
| SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY (H0203010401, Class IIb) | |
| device(s) / groups of device(s): | |
| Device Name: Disposable Endoscopic Linear Cutter Staplers and Reloads | Intended Purpose: The device has application in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. |
| Non-active non-implantable instruments (MDN 1208, class IIa) | |
| Group of Devices: Disposable Trocars | |
| Group of Devices: Veress needles | |
| Group of Devices: Disposable Hand Assist Tunnels | |
| Status | Valid |