6113714TD01
| Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter II and III | |
| 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 | |
| Class IIb Implantables | |
Basic UDI-DI: 69388737GMN001W8 Device Name: Esophageal Stent System Type: P050199, ESOPHAGEAL PROSTHESES – OTHER Models: GS-1-22-16060-18-700, GS-1-22-16080-18-700, GS-1-22-16100-18-700, GS-1-22-16120-18-700, GS-1-22-16140-18-700, GS-1-22-16160-18-700, GS-1-22-18060-18-700, GS-1-22-18080-18-700, GS-1-22-18100-18-700, GS-1-22-18120-18-700, GS-1-22-18140-18-700, GS-1-22-18160-18-700, GS-1-22-20060-18-700, GS-1-22-20080-18-700, GS-1-22-20100-18-700, GS-1-22-20120-18-700, GS-1-22-20140-18-700, GS-1-22-20160-18-700, GS-1-22-22060-18-700, GS-1-22-22080-18-700, GS-1-22-22100-18-700, GS-1-22-22120-18-700, GS-1-22-22140-18-700, GS-1-22-22160-18-700, GS-1-22-24060-18-700, GS-1-22-24080-18-700, GS-1-22-24100-18-700, GS-1-22-24120-18-700, GS-1-22-24140-18-700, GS-1-22-24160-18-700, GS-1-22-16060-24-700, GS-1-22-16080-24-700, GS-1-22-16100-24-700, GS-1-22-16120-24-700, GS-1-22-16140-24-700, GS-1-22-16160-24-700, GS-1-22-18060-24-700, GS-1-22-18080-24-700, GS-1-22-18100-24-700, GS-1-22-18120-24-700, GS-1-22-18140-24-700, GS-1-22-18160-24-700, GS-1-22-20060-24-700, GS-1-22-20080-24-700, GS-1-22-20100-24-700, GS-1-22-20120-24-700, GS-1-22-20140-24-700, GS-1-22-20160-24-700, GS-1-22-22060-24-700, GS-1-22-22080-24-700, GS-1-22-22100-24-700, GS-1-22-22120-24-700, GS-1-22-22140-24-700, GS-1-22-22160-24-700, GS-1-22-24060-24-700, GS-1-22-24080-24-700, GS-1-22-24100-24-700, GS-1-22-24120-24-700, GS-1-22-24140-24-700, GS-1-22-24160-24-700, GS-1-22-26060-24-700, GS-1-22-26080-24-700, GS-1-22-26100-24-700, GS-1-22-26120-24-700, GS-1-22-26140-24-700, GS-1-22-26160-24-700, GS-1-23-16060-18-700, GS-1-23-16080-18-700, GS-1-23-16100-18-700, GS-1-23-16120-18-700, GS-1-23-16140-18-700, GS-1-23-16160-18-700, GS-1-23-18060-18-700, GS-1-23-18080-18-700, GS-1-23-18100-18-700, GS-1-23-18120-18-700, GS-1-23-18140-18-700, GS-1-23-18160-18-700, GS-1-23-20060-18-700, GS-1-23-20080-18-700, GS-1-23-20100-18-700, GS-1-23-20120-18-700, GS-1-23-20140-18-700, GS-1-23-20160-18-700, GS-1-23-22060-18-700, GS-1-23-22080-18-700, GS-1-23-22100-18-700, GS-1-23-22120-18-700, GS-1-23-22140-18-700, GS-1-23-22160-18-700, GS-1-23-24060-18-700, GS-1-23-24080-18-700, GS-1-23-24100-18-700, GS-1-23-24120-18-700, GS-1-23-24140-18-700, GS-1-23-24160-18-700, GS-1-23-16060-24-700, GS-1-23-16080-24-700, GS-1-23-16100-24-700, GS-1-23-16120-24-700, GS-1-23-16140-24-700, GS-1-23-16160-24-700, GS-1-23-18060-24-700, GS-1-23-18080-24-700, GS-1-23-18100-24-700, GS-1-23-18120-24-700, GS-1-23-18140-24-700, GS-1-23-18160-24-700, GS-1-23-20060-24-700, GS-1-23-20080-24-700, GS-1-23-20100-24-700, GS-1-23-20120-24-700, GS-1-23-20140-24-700, GS-1-23-20160-24-700, GS-1-23-22060-24-700, GS-1-23-22080-24-700, GS-1-23-22100-24-700, GS-1-23-22120-24-700, GS-1-23-22140-24-700, GS-1-23-22160-24-700, GS-1-23-24060-24-700, GS-1-23-24080-24-700, GS-1-23-24100-24-700, GS-1-23-24120-24-700, GS-1-23-24140-24-700, GS-1-23-24160-24-700, GS-1-23-26060-24-700, GS-1-23-26080-24-700, GS-1-23-26100-24-700, GS-1-23-26120-24-700, GS-1-23-26140-24-700, GS-1-23-26160-24-700, GS-1-32-16060-18-700, GS-1-32-16080-18-700, GS-1-32-16100-18-700, GS-1-32-16120-18-700, GS-1-32-16140-18-700, GS-1-32-16160-18-700, GS-1-32-18060-18-700, GS-1-32-18080-18-700, GS-1-32-18100-18-700, GS-1-32-18120-18-700, GS-1-32-18140-18-700, GS-1-32-18160-18-700, GS-1-32-20060-18-700, GS-1-32-20080-18-700, GS-1-32-20100-18-700, GS-1-32-20120-18-700, GS-1-32-20140-18-700, GS-1-32-20160-18-700, GS-1-32-22060-18-700, GS-1-32-22080-18-700, GS-1-32-22100-18-700, GS-1-32-22120-18-700, GS-1-32-22140-18-700, GS-1-32-22160-18-700, GS-1-32-24060-18-700, GS-1-32-24080-18-700, GS-1-32-24100-18-700, GS-1-32-24120-18-700, GS-1-32-24140-18-700, GS-1-32-24160-18-700, GS-1-32-16060-24-700, GS-1-32-16080-24-700, GS-1-32-16100-24-700, GS-1-32-16120-24-700, GS-1-32-16140-24-700, GS-1-32-16160-24-700, GS-1-32-18060-24-700, GS-1-32-18080-24-700, GS-1-32-18100-24-700, GS-1-32-18120-24-700, GS-1-32-18140-24-700, GS-1-32-18160-24-700, GS-1-32-20060-24-700, GS-1-32-20080-24-700, GS-1-32-20100-24-700, GS-1-32-20120-24-700, GS-1-32-20140-24-700, GS-1-32-20160-24-700, GS-1-32-22060-24-700, GS-1-32-22080-24-700, GS-1-32-22100-24-700, GS-1-32-22120-24-700, GS-1-32-22140-24-700, GS-1-32-22160-24-700, GS-1-32-24060-24-700, GS-1-32-24080-24-700, GS-1-32-24100-24-700, GS-1-32-24120-24-700, GS-1-32-24140-24-700, GS-1-32-24160-24-700, GS-1-32-26060-24-700, GS-1-32-26080-24-700, GS-1-32-26100-24-700, GS-1-32-26120-24-700, GS-1-32-26140-24-700, GS-1-32-26160-24-700, GS-1-33-16060-18-700, GS-1-33-16080-18-700, GS-1-33-16100-18-700, GS-1-33-16120-18-700, GS-1-33-16140-18-700, GS-1-33-16160-18-700, GS-1-33-18060-18-700, GS-1-33-18080-18-700, GS-1-33-18100-18-700, GS-1-33-18120-18-700, GS-1-33-18140-18-700, GS-1-33-18160-18-700, GS-1-33-20060-18-700, GS-1-33-20080-18-700, GS-1-33-20100-18-700, GS-1-33-20120-18-700, GS-1-33-20140-18-700, GS-1-33-20160-18-700, GS-1-33-22060-18-700, GS-1-33-22080-18-700, GS-1-33-22100-18-700, GS-1-33-22120-18-700, 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GS-1-42-16080-18-700, GS-1-42-16100-18-700, GS-1-42-16120-18-700, GS-1-42-16140-18-700, GS-1-42-16160-18-700, GS-1-42-18060-18-700, GS-1-42-18080-18-700, GS-1-42-18100-18-700, GS-1-42-18120-18-700, GS-1-42-18140-18-700, GS-1-42-18160-18-700, GS-1-42-20060-18-700, GS-1-42-20080-18-700, GS-1-42-20100-18-700, GS-1-42-20120-18-700, GS-1-42-20140-18-700, GS-1-42-20160-18-700, GS-1-42-22060-18-700, GS-1-42-22080-18-700, GS-1-42-22100-18-700, GS-1-42-22120-18-700, GS-1-42-22140-18-700, GS-1-42-22160-18-700, GS-1-42-24060-18-700, GS-1-42-24080-18-700, GS-1-42-24100-18-700, GS-1-42-24120-18-700, GS-1-42-24140-18-700, GS-1-42-24160-18-700, GS-1-42-16060-24-700, GS-1-42-16080-24-700, GS-1-42-16100-24-700, GS-1-42-16120-24-700, GS-1-42-16140-24-700, GS-1-42-16160-24-700, GS-1-42-18060-24-700, GS-1-42-18080-24-700, GS-1-42-18100-24-700, GS-1-42-18120-24-700, GS-1-42-18140-24-700, GS-1-42-18160-24-700, GS-1-42-20060-24-700, GS-1-42-20080-24-700, GS-1-42-20100-24-700, GS-1-42-20120-24-700, 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GS-1-51-16140-24-700, GS-1-51-16160-24-700, GS-1-51-18060-24-700, GS-1-51-18080-24-700, GS-1-51-18100-24-700, GS-1-51-18120-24-700, GS-1-51-18140-24-700, GS-1-51-18160-24-700, GS-1-51-20060-24-700, GS-1-51-20080-24-700, GS-1-51-20100-24-700, GS-1-51-20120-24-700, GS-1-51-20140-24-700, GS-1-51-20160-24-700, GS-1-51-22060-24-700, GS-1-51-22080-24-700, GS-1-51-22100-24-700, GS-1-51-22120-24-700, GS-1-51-22140-24-700, GS-1-51-22160-24-700, GS-1-51-24060-24-700, GS-1-51-24080-24-700, GS-1-51-24100-24-700, GS-1-51-24120-24-700, GS-1-51-24140-24-700, GS-1-51-24160-24-700, GS-1-51-26060-24-700, GS-1-51-26080-24-700, GS-1-51-26100-24-700, GS-1-51-26120-24-700, GS-1-51-26140-24-700, GS-1-51-26160-24-700 | Intended Purpose: The esophageal stent system is used for expansion cure of esophageal, cardia and stomal stenosis. |