SHENZHEN, China, June 6 /Xinhua-PRNewswire/ -- Mindray Medical International Limited (NYSE: MR), a leading developer, manufacturer and marketer of medical devices worldwide, today announced it has received 510(k) clearance from the United States Food and Drug Administration ("FDA") for its DC-3 color ultrasound imaging system. The clearance comes in addition to China State Food and Drug Administration ("SFDA") approval and CE Mark granted earlier this year for the sale of the DC-3 in Chinese and European markets, respectively.
"The compact DC-3 combines outstanding 2D imaging and exceptional color Doppler performance," said Mr. Li Xiting, Mindray's president and co-chief executive officer. "With a superior price-to-performance ratio, we are confident that this versatile product will meet the diverse needs and requirements of hospitals, doctors' offices and veterinary clinics around the world."
The DC-3 color ultrasound imaging system is designed to have extensive applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets. The product is ideally suited for U.S. hospitals, doctors' offices and veterinary clinics seeking to replace black and white ultrasound imaging systems. The DC-3 is tailored to expand Mindray's customer base in low-end markets and complements the company's FDA-approved DC-6 and portable M5 ultrasound imaging systems, which are targeted for middle and high-end markets and received FDA 510(k) clearance in September, 2006 and March, 2008, respectively. The company currently offers over 10 medical imaging products of which five have received FDA 510(k) clearance.
Mindray has to date received FDA 510(k) clearance for a total of 16 products, covering patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems.
About Mindray
Mindray Medical International Limited is a leading developer, manufacturer and marketer of medical devices worldwide. Established in 1991, Mindray offers a broad range of products across three primary business segments: patient monitoring & life support products, in-vitro diagnostic products and medical imaging systems. Mindray is globally headquartered in Shenzhen, China, with U.S. headquarters in Mahwah, New Jersey. Mindray also has sales and service offices internationally in Amsterdam, Istanbul, London, Mexico City, Moscow, Mumbai, Sao Paulo, Seattle, Toronto and Vancouver. For more information, please visit http://www.mindray.com .
For investor inquiries please contact:
In China:
Susan Du
Mindray Medical International Limited
Tel: +86-755-2658-2518
Email: Susan.Du@Mindray.com
Justin Knapp
Ogilvy Public Relations Worldwide, Beijing
Tel: +86-10-8520-6556
Email: Justin.Knapp@Ogilvy.com
In the United States:
Jeremy Bridgman
Ogilvy Public Relations Worldwide, New York
Tel: +1-212-880-5363
