EU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III
Shanghai Aohua Photoelectricity Endoscope Co., Ltd.
No.66, Lane 133, Guangzhong Road, Minhang District
201108 Shanghai
P.R. China
SRN ID.: CN-MF-000030035
Active non-implantable imaging devices utilising non-ionizing radiation (MDA0202, Class IIa)
Group of Devices:
- Video Colonoscope
- Video Duodenoscope
- Video Gastroscope
- Video Bronchoscope
- Video Laryngoscope
- Video Choledochoscope
- Video Ureterorenoscope
- Video Cystoscope
- Endoscope imaging processor