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SITTARD, THE NETHERLANDS -- Oculus Innovative Sciences Netherlands B.V., a wholly owned subsidiary of Oculus Innovative Sciences of the United States, today announced that the company's first commercialized technology, the non-toxic Oculus Microcyn60 Disinfectant (OMD), has received CE approval under the European Medical Devices Directive 93/42/EEC. The super-oxidized OMD solution has proven to be environmentally friendly while effectively eradicating bacteria.
The newly obtained CE Mark is based on compliance with the recently developed EN 13727 European test for bactericidal efficacy. Under the supervision of the Dutch notified body (TNO), OMD is one of the first disinfectants to meet these new, more rigorous standards in Europe.
"We are elated with this initial CE Mark for OMD," said Hoji Alimi, president and founder of Oculus Innovative Sciences, "and are continuing to work with the European regulatory agencies as we pursue further approvals as a high-level disinfectant and eventually as an antiseptic."
The CE approval is also crucial to open other non-CE mark international markets such as Latin America, South Africa, Eastern Europe and the Middle East.
Microcyn's first regulatory approvals came from the Mexican Ministry of Health in July 2003, allowing for the use of Microcyn in Mexico as a commercial disinfectant for hard surfaces and medical devices, as well as an antiseptic for use on patients for the irrigation of wounds and in pre-operative skin preparation. The Ministry subsequently approved Microcyn for use as a high-level sterilant in November 2003. As well, the company successfully filed its application for approval of the Microcyn technology as a disinfectant with the United States Environmental Protection Agency in March 2004.
In addition to disinfecting of medical devices, Microcyn has shown great promise in the areas of food sterilization, veterinarian market, consumer products, wound healing, oral surgery and uses related to anti-bioterrorism. The disruptive Microcyn technology has created a buzz within global disinfectant and antiseptic industries due to its uniquely non-flammable, environmentally friendly and effective nature in rapidly killing viruses, bacteria, mold and spores.
Oculus Innovative Sciences, headquartered in Petaluma, Calif., is pioneering innovative life sciences and disruptive technologies that globally re-define the disinfectant and antiseptic markets. Oculus has developed the revolutionary Microcyn disinfectant and antiseptic with broad applications in such diverse markets as consumer, medical, dental, veterinarian, cosmetic, wound healing, food processing and anti-bioterrorism. The company has employees and operations in Mexico, Europe and the U.S. and includes two wholly owned subsidiaries, Oculus Technologies of Mexico, S.A. de C.V., and Oculus Innovative Sciences Netherlands B.V.
Source: Oculus Innovative Sciences Netherlands B.V.