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6168345CE01

EU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III
Manufacturer:
Suzhou Acuvu Medical Technology Co., Ltd.
B1-212, Bio-Nano Park, 218 Xinghu Street, Suzhou Industrial Park,
Suzhou Area, China (Jiangsu) Pilot Free Trade Zone,
215000 Suzhou, Jiangsu
China
SRN ID.: CN-MF-000038586
Active non-implantable imaging devices utilizing non-ionizing radiation (MDA 0202, Class IIa)
Device Name: HTx Disposable Hysteroscope