2014 CE Mark PR....
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Decision Diagnostics Corp. Subsidiary Pharma Tech Enters International Markets With Conformité Européenne (CE) Mark Submission
May 28, 2014
OTC Disclosure & News Service
Decision Diagnostics Corp. Subsidiary Pharma Tech Enters International Markets With Conformité Européenne (CE) Mark Submission
Company Also Announces Initial International Sales Endeavors
LOS ANGELES, CA--(Marketwired - May 28, 2014) - Decision Diagnostics Corp. (OTCQB: DECN), the manufacturer of the popular GenStrip™, the unique Green Glucose Test Strip, specifically designed to work with the Johnson & Johnson's (NYSE: JNJ) LifeScan Ultra family of glucose testing meters, announced today that they have engaged a European agent to complete its submission of Conformité Européenne (CE) Mark Technical File in order to obtain the EU market approval for the European version of its GenStrip™ 50 which will be marketed in Europe as the ValuPlus™ glucose sensor. CE Marking implies a medical device's compliance with European Union (EU) legislation and directives with respect to safety, health, environmental and consumer protection.
Keith Berman the Principal Executive Officer of DECN, commented, "Our GenStrip™ 50 product, currently available through retailers across the nation, is manufactured by an FDA registered and ISO certified contract manufacturing facility that is respected throughout the industry. We adhere to consistent and rigid quality procedures. All of the products produced routinely exceed the standards established by FDA. With the advent of our upcoming Conformité Européenne (CE) Mark Technical File application, we are enabling DECN, at a time of our choosing, to broaden our scope internationally, a seminal achievement."
CE Marking is necessary for commercialization of a medical device in member countries in the EU. DECN expects to receive its CE Marking in the second quarter of 2014 and is currently interviewing from a long list of potential distributors and other interested parties. The company is particularly close to choosing two distributors, and has already contracted with a third distributor of note from Eastern Europe.
Mr. Berman concluded, "Upon receiving the CE Mark approval, our ValuPlus™ glucose sensor will have become the world's first internationally endorsed alternative glucose test strip designed to work on the JNJ Lifescan family of glucose testing meters. We first received US FDA clearance for GenStrip™ in November 2012, and are continuing our sales efforts in a major way. We expect to announce additional domestic and foreign sales accomplishments in the coming weeks."
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