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 and drug injection products of Class III that conform to the laws and regulations of the State Food and Drug Administration (SFDA) and EU MDD.
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
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.
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
Operation principle
1、Quality first: to maximize the social responsibility, to ensure patients’ health
2、Management priority: Management ensures quality, management ensures benefit
3、Build harmonious enterprise: Improve employee welfare, create wealth for society, employees and shareholders.
4、Create Singclean brand: develop new products and improve product quality, establish brand image.