Medical Device Manufacturer · CN , Shenzhen

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

7 submissions · 7 cleared · Since 2018

Total

Cleared

Denied

Shenzhen Roundwhale Technology Co. , Ltd. has 7 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.

Latest FDA clearance: Jan 2024. Active since 2018. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Shenzhen Roundwhale Technology Co. , Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. as regulatory consultant.

Shenzhen Roundwhale Technology Co. , Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Shenzhen Roundwhale Technology Co. , Ltd.

7 devices

1-7 of 7

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 10, 2026