08/10/2015
Established in November of 2013, Elite Medtek (Jiangsu) is specialized in interventional medical device, including R&D, production, sales and other related service. Our products are mainly around medical consumables and accessories of high added value which are applicable to various interventional operations like angiography, balloon dilation and stent implantation etc. where Inflation Device, Coronary Control Syringe, Y-connector Pack, Pressuring Monitoring Tubing, Manifolds, Radial Artery Tourniquet and other related device are widely used.
Each kind of our present products for interventional operations is disposable sterile medical device. The production and microbiological detection area are designed scientifically and reasonably with 1,500 square meters building area including 600 square meters class 100,000 clean area, complying to Good Manufacturing Practice for Sterile Medical Device YY0033-2000 so as to ensure quality stability. Meanwhile, various professional production and testing equipment are allocated to different sections to meet related production conditions.
The company is certified to meet ENISO13485:2012 by TUV body in July of 2015 and is about to receive CE recently.
The company always upholds the quality policy that the safety and effectiveness of each product should be ensured by strictly complying with related laws and regulations, PDCA cycle should be applied anywhere, and the needs of customers should be concerned at anytime. Specific speaking, the company organize its production strictly according to the state standard, industry standard and registration standard, and control every sector that may influence the quality of the products to ensure high safety and effectiveness. The company’s mission is to contribute to the development of the health care enterprise of the nation, and continuously focus on the health of human beings worldwide.
