Contec Medical Systems Co.,Ltd - FDA 510(k) Cleared Devices

Contec Medical Systems Co., Ltd is a high-tech medical device manufacturer founded in 1996. The company is headquartered in Qinhuangdao, Hebei Province, China, with a manufacturing facility in Shanghai. Contec develops and distributes diagnostic and monitoring devices across multiple therapeutic areas.

The company has received 12 FDA 510(k) clearances from 12 total submissions between 2011 and 2024. Contec specializes in cardiovascular devices, including electronic sphygmomanometers, ambulatory blood pressure monitors, and electrocardiographs. The company also manufactures ultrasound diagnostic systems and fetal dopplers. All submissions have resulted in clearance, with no denials on record.

Contec maintains active FDA regulatory status, with the most recent clearance in 2024. The company is publicly listed on the Shenzhen Stock Exchange (Stock Code: 300869) and operates in over 130 countries. Contec holds ISO 9001, ISO 13485, and ISO 14001 certifications, and has obtained more than 100 national patents.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Beijing Believe-Med Technology Service Co., Ltd. as regulatory consultant.