Medical Device Manufacturer · CN , Shanghai

Xuzhou Kernel Medical Equipment Co., Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2014

Recent clearances: 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K), LED Light Therapy Device, KN-7000L, 308nm Excimer System

Total

Cleared

Denied

Xuzhou Kernel Medical Equipment Co., Ltd. has 8 FDA 510(k) cleared medical devices. Based in Shanghai, CN.

Latest FDA clearance: Feb 2025. Active since 2014. Primary specialty: General & Plastic Surgery.

Browse the FDA 510(k) cleared devices submitted by Xuzhou Kernel Medical Equipment Co., Ltd. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Guangzhou Keda Biological Tech Co., Ltd., Shanghai Truthful Information Technology Co., Ltd. and Guangzhou Junyi Information Technology Co., Ltd..

Xuzhou Kernel Medical Equipment Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.