6113714CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
| Manufacturer: | Changzhou New District Garson Medical Stent Apparatus Co., Ltd. No. 6, Huanbao 8 Road, Huanbao Industry Zone, New District 213022 Changzhou, Jiangsu P.R. China |
| Esophageal Prostheses-Other (P050199, class IIb implantable) | |
Device(s)/Group of device(s) - Esophageal Stent System | Intended Purpose: The esophageal stent system is used for expansion cure of esophageal, cardia and stomal stenosis. |
| Status | Valid |