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Dehaier gets SFDA nod for sleep apnea treatment device

19 September 2012 | News | By BioSpectrum Bureau

Dehaier Medical gets SFDA approval for sleep apnea treatment device

Dehaier Medical has received approval for a sleep apnea treatment device in China

Dehaier Medical has received approval for a sleep apnea treatment device in China

Singapore: Dehaier Medical has obtained State Food and Drug Administration's approval in China for DHR-CPAP-C5, one of Dehaier's major proprietary homecare medical devices. The period of validity for the SFDA approval is four years.

Continuous Positive Airway Pressure (CPAP) has become the first line of treatment for Obstructive Sleep Apnea Syndrome (OSAS) and for some forms of central sleep apnea. CPAP works by creating a pneumatic splint for the upper airway. A flow generator sends pressurized air through air tubing and a mask (usually a nasal mask) and through the nose to the upper airway. The pressurized air prevents the soft tissues of the upper airway from narrowing and collapsing. For proper CPAP treatment, patient can set high enough flow generator pressures to prevent apneas and hypopneas during all sleep stages and in all sleep positions. The SFDA approval indicated that DHR-CPAP-C5 has met the national health and safety standards and it will be launched in China soon.

Currently, DHR-998 (used for diagnosis and treatment evaluation) has been put into the international market upon receiving the CE Mark in 2011. Dehaier will continue to strengthen the domestic marketing effort for its high margin, proprietary homecare medical products and at the same time, explore new business model and strategic partnership.

Mr Ping Chen, chairman and chief executive officer of Dehaier Medical, said, "Developing and expanding the market share of homecare medical equipment has become one of the Dehaier's critical business strategies because we believe in the tremendous growth potential in Chinese homecare medical market. With great efforts on R&D, product upgrade, diversification of product mix and expansion of patents, Dehaier is well-prepared to not only educate the Chinese consumer about the homecare concept, but also serve the upcoming explosive demand for homecare medical equipment. We will seize any chance to become one of leading players in this promising market."

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