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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 name:
- Esophageal Stent System
Intended Purpose: The esophageal stent system is used for expansion cure of esophageal, cardia and stomal stenosis.