Medical Device Manufacturer · CN , Suzhou

Smartdata Suzhou Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2018

Total

Cleared

Denied

Smartdata Suzhou Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Suzhou, CN.

Historical record: 4 cleared submissions from 2018 to 2019. Primary specialty: Gastroenterology & Urology.

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

Regulatory submissions have been managed by Accelerated Device Approval Services and Third Party Review Group, LLC.

Smartdata Suzhou Co., Ltd. is one of 2194 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Smartdata Suzhou Co., Ltd.

4 devices

1-4 of 4

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Jun 03, 2026