Data / Medical devices / Thailand / Tianyi Medical (thailand) Co., Ltd.
Tianyi Medical (thailand) Co., Ltd.: FDA-registered device maker in PLUAKDAENG DISTRICT Rayong, Thailand, 1 510(k) clearance
Tianyi Medical (thailand) Co., Ltd. is registered with the FDA (registration 3042158867) in PLUAKDAENG DISTRICT Rayong, Thailand. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042158867
- Address
- 7/167 Moo 4, Mab Yang Phon Sub-District, PLUAKDAENG DISTRICT Rayong, Thailand, 21140
- Owner or operator
- Tianyi Medical (Thailand) Co., Ltd. (10094306)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- November 21, 2025
- Registered through
- 2026
- Brand names listed
- Extracorporeal Blood Tubing Set, TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, Contract sterilizer | 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 |
|---|---|---|---|---|---|---|
| October 2, 2025 | K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | FJK | Substantially Equivalent | Ningbo Tianyi Medical Appliance Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Updated October 2, 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.