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6115270CE01

EU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III
Sinolinks Medical Innovation, Inc
No.10 Ziwei Road, Zhonglou Zone
Changzhou 213023 Jiangsu
China
SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY (H0203010401, Class IIb)
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