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Certificate
公
No. Q5 050972 0053 Rev. 00
限
有
Holder of Certificate: Contec Medical Systems Co., Ltd.
份
No.112 Qinhuang West Street
Economic& Technical Development Zone
股
066004 Qinhuangdao, Hebei Province
PEOPLE'S REPUBLIC OF CHINA
)
Certification Mark:
岛
皇
秦
有
(
所
统
司
Design and Development, Production, Sales, Installation and
Scope of Certificate:
系
本
Servicing of Dynamic EEG Systems, Dynamic ECG Systems, Digital
Brain Electric Activity Mapping, Patient Monitor, Patient Monitor
学
归
System, B-Ultrasound Diagnostic System, ECG Recorder, ECG
Workstation, ECG Monitor System, Medical Image Workstation,
医
权
Fetal Monitor, Ventilator, Anesthetic Machine, High Frequency
Surgical Unit, Pulse Oximeter, Pocket Fetal Doppler, Visual
泰
司
Spirometer, Ambulatory Blood Pressure Monitor, Electronic
解
Infrared Thermometer.
必
The Certification Body of TÜV SÜD Product Service GmbH certifies that the company mentioned above has
股
established and is maintaining a quality management system, which meets the requirements of the listed
图
standard(s). All applicable requirements of the testing and certification regulation of TÜV SÜD Group have to be
)
complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:Q5 050972 0053 Rev. 00
盗
Page 1 of 2
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany
司
Certificate
公
No. Q5 050972 0053 Rev. 00
限
有
Applied Standard(s): EN ISO 13485:2016
份
Medical devices - Quality management systems -
Requirements for regulatory purposes
股
(ISO 13485:2016)
DIN EN ISO 13485:2016
)
Facility(ies): Contec Medical Systems Co., Ltd.
岛
No.112 Qinhuang West Street, Economic& Technical
Development Zone, 066004 Qinhuangdao, Hebei Province,
皇
PEOPLE'S REPUBLIC OF CHINA
秦
有
See Scope of Certificate
(
所
统
司
系
本
学
归
医
权
泰
释
康
司
解
公
终
限
最
有
究
份
必
股
图
)
盗
岛
皇
秦
(
统
系
学
医
泰
康
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TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany