Data / Medical devices / South Korea / ATsens Co., Ltd.
ATsens Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 1 510(k) clearance
ATsens Co., Ltd. is registered with the FDA (registration 3024821700) in Seongnam-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024821700
- Address
- Point Town 803 and 806, 11, Gumi-ro, Bundang-gu, Seongnam-si Gyeonggi, South Korea, 13637
- Owner or operator
- ATsens Co., Ltd (10079672)
- Roles
- Manufacturer
- First device listed
- July 24, 2025
- Registered through
- 2026
- Brand names listed
- AT-Note, AT-Patch, AT-Report
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 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 |
|---|---|---|---|---|---|---|
| May 2, 2025 | K242583 | AT-Patch (ATP-C130/ATP-C70) | DSH | Substantially Equivalent | Atsens Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 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.