BEIJING, March 24 /Xinhua-PRNewswire-FirstCall/ -- China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based medical device company that develops, manufactures and markets advanced in- vitro diagnostic ("IVD") products and high intensity focused ultrasound tumor therapy systems, today announces that the Company receives the Conformite Europeenne Mark ("CE Mark") for its two semi-automatic ECLIA analyzers and 15 reagents.
Under the In-Vitro Diagnostic Directive ("IVDD") of the European Union ("EU"), products must meet regulatory requirements in order to qualify for sales and distributions in the EU. A CE Mark indicates that a product complies with the EU regulatory requirements. The Company receives the CE Mark for its two semi-automatic ECLIA analyzers and 15 reagents, including thyroid disorders, diabetes and tumor marker reagents.
"The CE Mark demonstrates that our products meet the IVDD requirements," said Mr. Xiaodong Wu, Chairman and CEO of the Company. "It not only allows us access to new markets but also strengthens our leading position in the advanced IVD market in China."
ECLIA system is a closed IVD system including an analyzer and reagents that are used to detect and quantify particular antibodies or antigens for the diagnosis and analysis of various diseases and disorders. The Company will continue to work on receiving CE Mark for its other ECLIA reagents.
About China Medical Technologies, Inc.
China Medical Technologies is a leading China-based medical device
company that develops, manufactures and markets advanced in-vitro
diagnostic products using Enhanced Chemiluminescence (ECLIA) technology and
Fluorescent in situ Hybridization (FISH) technology, to detect an
|SOURCE China Medical Technologies, Inc.|
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