8613362195396
Marketing@hzxhe.com
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General Information

Hangzhou Singclean Medical Products Co., Ltd., established in 2002 with registered capital of 80,000,000 RMB, is a national high and new technology enterprise integrating the R&D, production and sales of medical biomaterials. With highly-qualified staff, thorough quality management system and first-class facilities, the company ensures the continuous production of medical devices of Class III that conform to the laws and regulations of NMPA and EU MDR.

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    10 million euros

     

    Register capital

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    500+

     

    Staff members

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    85 million euros

     

    Annual Sales

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    12 +million pieces

     

    Productivity

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    50+ countries

     

    Obtained local registration

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    120+

     

    Sales channels(countries and regions)

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    10%+ of revenue

     

    Spent on R&D each year

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    330+ global

     

    OEM ODM OBL partners

Quality system

ISO9001 Quality Management System Certification

ISO13485 Medical Devices Quality Management System Certification

Medical Device Directive (MDD93/42/EEC)

In-Vitro Diagnostic Devices Directive (IVDD98/79/EC)

GB/T19001-2008

YY/T0287-2003

Good Manufacturing Practice for Medical Products, GMP(Revised in 2010)

Good Manufacturing Practice for In Vitro Diagnostic Reagents

Good Manufacturing Practice for Medical Devices

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Besides, based on the quality management systems above, Singclean Medical has also set up a documentation-based quality management system using quality objectives, audit results, data analysis, corrective and preventive actions and management review to maintain strict quality control.
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Technological Innovation

Singclean Medical has always placed great emphasis on research and development of products, 10% of the yearly total sales revenue has been invested in R&D each year to develop innovative products and introduce advanced equipments. Singclean Medical R&D center is equipped with Class 10,000 cleanroom (including Class 100) with a total area of more than 200 m². Also, Singclean has acquired a number of patent technologies in the past years. The company obtained the certification of high and new technology enterprise of Hangzhou in 2007, of Zhejiang Province in 2008, of China in 2010, and the medical sodium hyaluronate gels got the CE certification in 2011. To emphasize the integration of production, education and research, and make full use of the advantages of colleges and universities in cultivating talents and developing technologies, Singclean Medical has built a joint research center with Zhejiang University of Science and Technology, well established R&D cooperation relations with Zhejiang University, Donghua University and Zhejiang University of Technology and invited a lot of well-known experts to be the company's technical consultants.

Company Culture

 

Professional Perfect Practical

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    Quality first

    To maximize the social responsibility, to ensure patients' health

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    Management priority

    Management ensures quality, management ensures benefit

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    Build harmonious enterprise

    Improve employee welfare, create wealth for society, employees and shareholders.

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    Create Singclean brand

    develop new products and improve product quality, establish brand image.

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    Our Mission

    Serve patients ; Improve patients' health ; Improve medical treatment level in China

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    Our Vision

    To be the leading manufacturer of absorbable biomaterials in China