SHENZHEN, China, June 6 Mindray MedicalInternational Limited (NYSE: MR), a leading developer, manufacturer andmarketer of medical devices worldwide, today announced it has received 510(k)clearance from the United States Food and Drug Administration ("FDA") for itsDC-3 color ultrasound imaging system. The clearance comes in addition to ChinaState Food and Drug Administration ("SFDA") approval and CE Mark grantedearlier 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 colorDoppler performance," said Mr. Li Xiting, Mindray's president and co-chiefexecutive officer. "With a superior price-to-performance ratio, we areconfident that this versatile product will meet the diverse needs andrequirements of hospitals, doctors' offices and veterinary clinics around theworld."
The DC-3 color ultrasound imaging system is designed to have extensiveapplications in abdominal, OB/GYN, endovaginal, cardiac, small parts andpediatric markets. The product is ideally suited for U.S. hospitals, doctors'offices and veterinary clinics seeking to replace black and white ultrasoundimaging systems. The DC-3 is tailored to expand Mindray's customer base inlow-end markets and complements the company's FDA-approved DC-6 and portableM5 ultrasound imaging systems, which are targeted for middle and high-endmarkets and received FDA 510(k) clearance in September, 2006 and March, 2008,respectively. The company currently offers over 10 medical imaging products ofwhich five have received FDA 510(k) clearance.
Mindray has to date received FDA 510(k) clearance for a total of 16products, covering patient monitoring and life support products, in-vitrodiagnostic products and medical imaging systems.
Mindray Medical International Limited is a leading developer, manufacturerand marketer of medical devices worldwide. Established in 1991, Mindray offersa broad range of products across three primary business segments: patientmonitoring & life support products, in-vitro diagnostic products and medicalimaging systems. Mindray is globally headquartered in Shenzhen, China, withU.S. headquarters in Mahwah, New Jersey. Mindray also has sales and serviceoffices 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
SOURCE Mindray Medical International Limited