Data / Medical devices / South Korea / TNS Co.,ltd
TNS Co.,ltd: FDA-registered device maker in Geumcheon-gu, Seoul, South Korea, 2 510(k) clearances
TNS Co.,ltd is registered with the FDA (registration 3017220679) in Geumcheon-gu, Seoul, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017220679
- Address
- 402,, 100, Gasan Digital 1-ro, Geumcheon-gu, Seoul, Geumcheon-gu, Seoul, South Korea, 08590
- Owner or operator
- TNS CO.,LTD (10090257)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- March 10, 2024
- Registered through
- 2026
- Brand names listed
- Serafin®
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 11, 2025 | K251758 | Serafin® | NXC | Substantially Equivalent | Tns Co., Ltd. | accessdata.fda.gov |
| February 22, 2024 | K232074 | Serafin® | NXC | Substantially Equivalent | Tns Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 11, 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.