Data / Medical devices / China / Shenzhen Trious Medical Technology Co., Ltd
Shenzhen Trious Medical Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Trious Medical Technology Co., Ltd is registered with the FDA (registration 3033848208) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 3, 2025. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3033848208
- Address
- Rm B102 Bldg B4 Rm 401 402 Bldg D3 YingZhan S T Estate Longtian Tongfuyu Rd 8 Longtian Com Longtian St Pingshan, Shenzhen Guangdong, China, 518118
- Owner or operator
- Shenzhen Trious Medical Technology Co., Ltd (10091653)
- Roles
- Manufacturer
- First device listed
- October 22, 2024
- Registered through
- 2027
- Brand names listed
- Disposable Percutaneous Nephrostomy Dilators, Disposable Ureteral Access Sheath, Disposable kidney stone retrieval basket, Disposable non-vascular guide wire, Disposable ureteral stent, Negative pressure drainage device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Nephrostomy | LJE | U | Manufacturer | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | 2 | Manufacturer | accessdata.fda.gov |
| Evacuator, Gastro-Urology | KQT | 2 | Manufacturer | accessdata.fda.gov |
| Stent, Ureteral | FAD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 3, 2025 | K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | LJE | Substantially Equivalent | Shenzhen Trious Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 14, 2025 | K243830 | Disposable ureteral stent | FAD | Substantially Equivalent | Shenzhen Trious Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 11, 2025 | K243710 | Disposable ureteral access sheath | FED | Substantially Equivalent | Shenzhen Trious Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Endoscopic Guidewire, Gastroenterology-Urology
- All makers of Catheter, Nephrostomy
- All makers of Stent, Ureteral
- All makers of Evacuator, Gastro-Urology
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
Updated July 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.