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6086735CE01

EU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III
ManufacturerANKON Medical Technologies (Shanghai) Co., Ltd.
1/F, 435 Chuanqiao Road, China (Shanghai) Pilot Free-Trade Zone
201206 Shanghai
China
SRN ID.: CN-MF-000010409
Device(s)/Group of device(s)Other 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 MarkersStatus
StatusValid