DEKRA德凯证书6124105CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
| Manufacturer: | Hunan Endoso Life Technology Co., Ltd. 4th floor, Building 10, Innovation and Entrepreneurship Center, No. 31, Dongfeng Road, Heping Street, Xiangtan Economic Development Zone 411199 Xiangtan, Hunan P.R. China SRN ID.: CN-MF-000021400 |
| device(s) / groups of device(s): | |
| Active non-implantable imaging devices utilizing non-ionizing radiation (MDA 0202, Class IIa) | |
| Group of Devices: Single-Use Bronchoscope | |
| Group of Devices: Single-Use Digital Flexible Ureteroscope | |
| Group of Devices: Monitor for Single-Use Endoscopy | |
| Group of Devices: Single-use Choledochoscope | |
| Group of Devices: Single-use Cystoscope | |
| Status | Valid |