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Setting

6118114CE01

EU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III
Manufacturer
Yian Medical Technology (Haining) Co., Ltd.
1st Floor Area 1,2nd Floor Area 1, Building A, No. 2 Caohejing Road,
Haining Economic Development Zone, Haichang Street, Haining City
314400 Jiaxing City, Zhejiang Province
China
DIRECT DIGITAL X-RAY SYSTEMS (Z110311, class IIb)
Group of Devices:
Digital Mobile Photographic X-ray Machine 		Intended Purpose: Mainly used for chest, abdomen, limbs and other parts (spine and pelvis) of X-ray photography examination, image for clinical diagnosis.