6086735CE01

CompanyANKON Medical Technologies (Shanghai) Co., Ltd.
AddressNo. 2218, Jinsui Road, China (Shanghai) Pilot Free Trade Zone,
Pudong New Area
200120 Shanghai
China
RegulationEU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III
ProductOther active non-implantable devices for monitoring and / or diagnosis (MDA0204, Class IIa)
Device Name: Capsule Endoscope Controllers: NaviCam Xpress Controller
Non-active non implantable diagnostic devices (MDN1207, class IIa)
Device Name: IntraMarX Radiopaque Markers