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6086865CE01

EU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III
ManufacturerShenzhen Lifotronic Technology Co., Ltd.
Lifotronic Tower, No.8, Qiuzhi East Road, Guancheng Community
Guanhu Street, Longhua
518110 Shenzhen
P.R.China
SRN ID.: CN-MF-000005654
Active non-implantable devices for stimulation or inhibition(MDA0305, class IIa)
Group of Devices: Shock Wave Therapy Systems
BODY THERMOREGULATION EQUIPMENT (Z12040208, class IIb)
Group of Devices: Temperature Management SystemIntended Purpose: The Temperature ManagementSystem is intended to prevent and treat hypothermia foradult and pediatric patients.
Status
Valid