Medical Device Manufacturer · CN , Shenzhen

Shenzhen Changkun Technology Co., Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2020

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Shenzhen Changkun Technology Co., Ltd. Cardiovascular ✕

2 devices

1-2 of 2

Regulatory consultants 510(k) submission support ecosystem

Guangzhou GLOMED Biological Technology Co., Ltd.

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 15, 2026