 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 19.0076-01 | Issue No.: | 3 | Status: | Current |
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| Supersedes: | IECQ-H SGSCN 19.0076-01 Issue 2 | Issue Date: | 2023/12/02 | Site Added: | 2019/09/10 |
| CB Reference No.: | CN19/31506.01 | Expiration: | 2025/09/09 |  | |
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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 Mindray Bio-Medical Electronics Co., Ltd.
No. 1203 Nanhuan Avenue, Guangming District,
Shenzhen, 518106, 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 and manufacture Medical Electronic Equipment (including Hematology Analyzer, Clinical Chemistry Analyzer, Urine Analyzer, Microplate Reader, Microplate washer for In-Vitro Diagnostic Use, Chemiluminescence Immunoassay Analyzer, Automated Digital Cell Morphology Analyzer, Flow Cytometer, (Auto) Sample Processing System, Auto Slide Maker and Stainer, Glycohemoglobin Analyzer, Specific Protein Analyzer, lon-Selective Electrodes, Automated Digital Cell Morphology Analyzer, Coagulation Analyzer and Accessories Manufacture of Medical Electronic Equipment (including Patient Monitor and Accessories, Vital Signs Monitor, Central Monitoring System, Telemetry Monitoring System, Pulse Oximeter, Defibrillator/Monitor and Accessories, Electrocardiograph, Anesthesia Machine and Accessories, Ventilator, Air Compressor, Endoscope Camera System, Endoscope Light Source and Accessories, Ultrasonic Diagnostic Equipment and Accessories, Digital Radiography System, Tympanic Thermometer)
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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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