 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 20.0027-06 | Issue No.: | 2 | Status: | Current |
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| Supersedes: | IECQ-H SGSCN 20.0027-06 Issue 1 | Issue Date: | 2025/05/14 | Site Added: | 2024/05/27 |
| CB Reference No.: | CN22/00000729.06 | Expiration: | 2028/05/13 |  | |
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Applicable to: - EU 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.
Floor 302 Unit B, Floor 3&4 Unit A, Building 1, Guancheng Sanliang Industrial Park, No. 2 of Xingguangchenxing Road, Huangjiang Town, Dongguan, Guangdong Province, 523000, 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: |
Warehouse management in support of the Design, development, manufacture and sales of Electronic endoscope, Functional Supply of Medical Endoscopy, Operating Table, Ceiling Pendant, Surgical Light Devices, Temperature Control Systems/Devices, T piece Infant Resuscitation System, Infant Radiant Warmer, Medical Infant Bessinet, Infant/Neonatal Incubator, High Frequency Chest Wall Oscillator, Anaesthetic machine, Auxiliary Devices of Anaesthetic, Ventilator, Auxiliary Devices of Ventilator, Infusion Pump, Syringe Pump, Infusion Workstation System, Phototherapy Devices, External Defibrillator Devices, Patient Monitor Devices, Accessories of Patient Monitor Devices, Specialized Fetal & Maternal Monitor and Accessories, Electrocardiograph, Infrared Ear Thermometer, Central Monitoring System, Sequential Compression System and Accessories and design and development of Automatic CPR (Cardiopulmonary Resuscitation) Machine, ICP (Intracranial pressure monitor) Monitor and Accessories
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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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