Medical Device Manufacturer · TH , Tambon Khao Kwai, Amphur Phunphin

Suretex Limited - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2022

Total

Cleared

Denied

Suretex Limited has 6 FDA 510(k) cleared medical devices. Based in Tambon Khao Kwai, Amphur Phunphin, TH.

Latest FDA clearance: Nov 2025. Active since 2022. Primary specialty: Obstetrics & Gynecology.

Browse the FDA 510(k) cleared devices submitted by Suretex Limited Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by C3-Carey Consultants, LLC and Digangi Consulting, LLC.

Suretex Limited is one of 32 FDA 510(k) medical device manufacturers from Thailand in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Suretex Limited

6 devices

1-6 of 6

Data Source

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

Last updated: Apr 27, 2026