OxySure Systems, a medical technology company that has pioneered an FDA-approved solution to produce medically pure oxygen from dry, inert powders for emergency/short duration use, this morning gave investors a progress report on the CE Marking of its flagship product, the OxySure Model 615.
The company received notice earlier this month of an opinion rendered by the Medicines and Healthcare products Regulatory Authority (MHRA) in the United Kingdom related to the classification of the OxySure Model 615 as a medical device. An opinion of this nature by a competent authority is a key step in the CE Marking process.
“We are pleased with this opinion from MHRA,” commented Mark Gilmore, Managing Partner of Aero Healthcare, OxySure’s partner in the United Kingdom. Gilmore, who oversees the CE Marking process, added, “In addition, we have already substantially completed our technical file for the CE Marking process and we plan to move forward post haste with our notified body on the next steps of the CE Marking of OxySure.”
The CE marking will enable the free movement and sale of products within the European market. With the marking, OxySure’s approved products can be sold in approximately 31 countries in the European Economic Area (EEA), comprising the 28 Member States of the European Union and the European Free Trade Association (EFTA) countries of Iceland, Norway, and Liechtenstein. As of January 1, 2012, the population of the European Union was approximately 503.5 million people.
For more information, visit www.OxySure.com
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