Data / Medical devices / South Korea / Winus Technology Co., Ltd.
Winus Technology Co., Ltd.: FDA-registered device maker in Gun Po Si Gyeonggi, South Korea, 1 510(k) clearance
Winus Technology Co., Ltd. is registered with the FDA (registration 3007518359) in Gun Po Si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 23, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007518359
- Address
- 5F, 298-7, Gongdan-ro, Gun Po Si Gyeonggi, South Korea, 15809
- Owner or operator
- WinUs Technology Co., Ltd. (10028427)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 29, 2009
- Registered through
- 2026
- Brand names listed
- Dexcam3, Dexcam4, Dexcam4 HD, GXC300, Raycam, Raycam Plus, Smartcam
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Operative Dental | EIA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 23, 2004 | K040691 | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D | EIA | Substantially Equivalent | Win-Us Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 23, 2004. 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.