Dehaier sleep apnea medical device receives SFDA approval

BEIJING – Dehaier Medical Systems Ltd said it has obtained approval from China’s State Food and Drug Administration (SFDA) for its DHR-CPAP-C5 homecare medical device. The SFDA approval is valid for four years and indicates that DHR-CPAP-C5 has met the national health and safety standards. The device will be launched in China soon.

The standard treatment for Obstructive Sleep Apnea Syndrome (OSAS) and some forms of central sleep apnea usually involves Continuous Positive Airway Pressure (CPAP), which works by creating a pneumatic splint for the upper airway. A flow generator then sends pressurized air, which prevents soft tissues of the upper airway from collapsing, through air tubing and a mask and through the nose to the upper airway.

Dehaier Medical’s DHR-998 device, used for diagnosis and treatment evaluation of OSAS, has been put into the international market after receiving the EU CE Mark in 2011.

"We are excited about the recent SFDA approval for DHR-CPAP-C5 which is another important step towards providing complete solution to fight sleep disorders," said Mr Ping Chen, chairman and chief executive officer of Dehaier Medical. "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."