Zhejiang Quzhou Rongbo Medical Instruments Co., Ltd, established in 2017, is a company specialized in manufacturing sterile medical devices for single use as well as registered in CFDA (China Food and Drug Administration). The company, with registered capital of 5,28 million CNY, is mainly to produce and sell all kinds of sterile products, e.g. sterile hypodermic syringes with needle for single use, infusion sets with needle for single use and infusion sets with precision filters for single use. The company has established market network all over the Chinese mainland as well as extended to overseas’ markets of Middle East Area, Pakistan, Syria, Argentina and Singapore, etc. The company covers an area about 20,000 m2 with a construction area of 14, 150 m2, among which there is class 100,000-level clean workshop with area of 4,766 m2 and two autoclaves, one with area of 15 cubic meter and the other with area of 25 cubic meter. In addition, so far there is 70 employees working for the company, including one employee responsible for engineering and technical issues, three internal auditors and two inspectors for physical and chemical inspection.
In the year of 2017, there are two products get the certificate of registration for medical devices issued by CFDA (China Food and Drug Administration), one product is sterile hypodermic syringes with needle for single use and the other one is infusion sets with needle for single use.
Our company has the capability to produce all covered products with appropriate manufacturing equipment, production site, warehouse area and proper working environment applicable for the production scale. In addition, there is a completed quality management system is established and operated in the company. The manufacturing shops follow up GMP requirement to take advanced cross flow ways, using central air conditioning and air cleaning system to control temperature and humidity of cleanrooms. In the meantime, clean class of the cleanrooms will be inspected regularly to ensure the clean area comply with the requirement for class 100,000-level clean workshop. There is a completed quality monitoring system operated in the company and quality across all production segments are strictly controlled following process procedures. The quality department has a complete working structure as well as sufficient test facilities. Therefore our company has sufficient quality inspection ability appropriate for the product range and production scale.
In the recent years, the company always concentrates on the aspects of legitimate business, standard production and custom focus. There is new progress whatever on employees’ personnel quality and management level. Quality of products is stable and reliable. The Quality qualification rate is 100% in all kinds of spot checks monitored at national or provincial level. Our company also has the good ability for research and development of new products.
All medical institutions and pharmaceutical companies are warmly welcomed to cooperate with our company and to contribute our sincerity and love for human beings health undertakings together.
