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