6126407TD01
| EU Technical Documentation Assessment Certificate | |||
| Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter II and III | |||
| Manufacturer | Micro-Tech (Nanjing) Co., Ltd. | ||
| Address | No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone 210032 Nanjing, Jiangsu Province P. R. China | ||
| Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis (MDN 1202, class IIa) | |||
| Class IIb Implantables | |||
Basic UDI-DI: 6902284ETP0501A1TX Device Name: Esophageal Stent Type: P050199, Esophageal Prostheses-Other Model: STXX - AAB.DD.LLL, N/M STXX - AAB-DD.LLL | Intended Purpose: The Esophageal Stent implant is indicated for use in the palliative treatment of esophageal stricture caused by malignant neoplasms, cardia stricture, anastomotic stoma stricture, and the esophageal fistula occluding. | ||
| Expiry Date | 1 August 2028 | ||