司

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

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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

Stethoscope, Electric Suction Apparatus, Transcranial Doppler

Analysis System, Maternal/Fetal Monitor, Infusion Pump,
康

司
Spirometer, Ambulatory Blood Pressure Monitor, Electronic
解

Sphygmomanometer, EMG/EP System, Pulse Oximeter Probe,

公
Temperature Probe, ECG Electrode Cable And Accessories, Blood
终

Pressure Cuff, Portable ECG Monitor, Semi-auto Biochemistry

限
Analyzer, Urine Analyzer, Oxygen concentrator, Multi-parameter
最

Vital Signs Monitor, Remote ECG Monitor, Sleep apnea screen

有

meter, Arteriosclerosis Detector, Compressor Nebulizer, Wearable

Monitor, Predictive Thermometer, Mesh Nebulizer, Capnograph and
究

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

Report No.: BJ21090203

岛

Valid from: 2022-03-02

皇

Valid until: 2025-03-01

秦
（

Date, 2022-02-24 Christoph Dicks

统

Head of Certification/Notified Body

系
学
医
泰
康

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

Page 2 of 2
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany