Medical Device Manufacturer · CN , Hangzhou

Assure Tech. Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2015

Total

Cleared

Denied

Assure Tech. Co., Ltd. has 3 FDA 510(k) cleared medical devices. Based in Hangzhou, CN.

Historical record: 3 cleared submissions from 2015 to 2016. Primary specialty: Chemistry.

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

510(k) submissions have been managed by Lsi International as regulatory consultant.

Assure Tech. Co., Ltd. is one of 1971 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Assure Tech. Co., Ltd.

3 devices

1-3 of 3

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 22, 2026