China Sky One Medical, a provider of medical diagnostic kits and drugs, in the People's Republic of China (PRC), has received Conformite Europeenne (CE) certification for its Myocardial Infarction and Urine Microalbumin Diagnostic Kits.
The company said that the CE marking certifies that the two products have met the European Union (EU) health and safety standards and are approved for sale in the 27 EU countries and four members of the European Free Trade Association (EFTA).
The company has also received ISO 9001 and ISO 13485 certifications for its Myocardial Infarction, Urine Microalbumin and Early Pregnancy Diagnostic Kits. ISO certifications set stringent, a recognized management system standard that enhances its product marketing. The two ISO certifications are valid through October 2014.
Yan-Qing Liu, chairman and CEO of China Sky One Medical, said: “We are honored to receive the CE marking and the ISO certifications, which reinforce the high quality of our products and manufacturing standards and pave way for exporting the diagnostic kits in the EU and other markets.
“According to agreements with our distributors in Indonesia, Turkey, Singapore and Vietnam, we will enter into definitive contracts with the distributors following receipt of the CE marking. The CE marking and ISO certifications also strengthen the Company’s ability to advance our negotiations with potential distributors from many other countries. We look forward to launching our diagnostic kits in promising international markets beginning in 2010.”