San Diego, California – November 20, 2008 — Entra Health Systems, an international applied healthcare technology company today announced the receipt of CE Mark Certification for the MyGlucoHealth® Meter. The new meter is the most technically advanced diabetic patient care product on the market today. It features a fully integrated Bluetooth®-enabled test upload system, rapid testing results, which are available in 3 seconds, the smallest blood sample size (.3μL) of any meter and automatic coding of test strips.
“CE certification confirms that the MyGlucoHealth Meter meets all the CE Mark requirements, which involve rigorous testing to European and International standards for product safety, compatibility and performance,” said Richard C. Strobridge, Chief Executive Officer of Entra Health Systems. “The company will begin shipment of the new meters to Europe by the end of the month to meet growing demand.”
The MyGlucoHealth Meter officially received CE Certification in Europe on November 20, 2008. The device registration number in Europe is 21.34.02.1078. CE is the European conformity marking that indicates that the product complies with all relevant European requirements, and that it has been evaluated according to applicable certification procedures.
The CE marking (an acronym for the French “Conformite Europeenne”) certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. A manufacturer, who has gone through the conformity assessment process, may affix the CE marking to the product.