 IEC QUALITY ASSESSMENT SYSTEM (IECQ)
For rules and details of the IECQ visit www.iecq.org |
IECQ Certificate of Conformity
Hazardous Substance Process Management |
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| IECQ Certificate No.: | IECQ-H SGSCN 20.0027-01 | Issue No.: | 1 | Status: | Superseded |
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| Supersedes: | | Issue Date: | 2022/05/14 | Site Added: | 2022/05/14 |
| CB Reference No.: | CN22/00000729.01 | Expiration: | 2025/05/13 |  | |
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Applicable to: - European Directive 2011/65/EU (“RoHS – Restriction of the use Of certain Hazardous Substances”) in electrical and electronic equipment. Including all published amendments
Shenzhen Comen Medical Instruments Co., Ltd.
Unit 501, West Side of the Fifth Floor of the Machinery Factory (No. 2 Area of Chuangxiang), Yanxiang Technology Industrial Park, No. 11 of Gaoxin West Road, Guangming Street, Shenzhen, Guangdong, P.R.
China
The organization has developed and implemented restricted/hazardous substances process management procedures and related processes which have been assessed by IECQ Certification Body in accordance with IECQ 03-1 and IECQ 03-5 for the issuance of this certificate and found to be in conformity with the applicable requirements to the IECQ Hazardous Substances Process Management Scheme and in respect of the IECQ Specification: |
- IECQ QC 080000:2017 - Hazardous Substance Process Management System Requirements
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This Certificate is applicable for the following scope of activity: |
Design, Production and Sales of Fetal & Maternal Monitor, Multi-parameter Patient Monitor, Specialized Cardiovascular Monitor, Vital Signs Monitor, Specialized Neonatal Monitor, Specialized Fetal & Maternal Monitor, Defibrillator Monitor, Central Monitoring System Software, Anaesthetic Gas Scavenging System, Infant Incubator, T-piece Infant Resuscitation System, Electrocardiograph, Infrared Ear Thermometer, Anaesthesia Machine, Infusion Pump, Infusion Workstation, Syringe Pump, Neonatal Ventilator, Medical Oxygen-air Blender, Medical Air Compressor, Ceiling Pendant, LED Surgical Light, Infant Radiant Warmer, Infant Phototherapy Equipment, Catheter-positioning Guiding System, Temperature Control Device, Temperature Control System for management patient body temperature, Video Laryngoscope, Sequential Compression System, High Flow Heated Respiratory Humidifier, Emergency, Transport Ventilator, Ventilator and Electric Comprehensive Operating Table.
Design and Sales of Sterile disposable laryngoscope blade
This address only products storage process
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Issued by the Certification Body: SGS-CSTC Standards Technical Services Co. Ltd. |
16F Century YuHui Mansion, 73 Fucheng Road, Beijing
China
Authorised Person:
Tsang Ben
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The validity of this certificate is maintained through on-going surveillance audits by the IECQ CB issuing this certificate.
This Certificate of Conformity may be suspended or withdrawn in accordance with the Rules of Procedure of the IECQ System and its Schemes. This certificate and any schedule(s) may only be reproduced in full. This certificate is not transferable and remains the property of the issuing IECQ CB. The Status and authenticity of this certificate may be verified by visiting www.iecq.org.
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IECQ-H Rev. 9.0 EN
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