Data / Medical devices / Taiwan / Hjy Smart Medical Device Co., Ltd.
Hjy Smart Medical Device Co., Ltd.: FDA-registered device maker in Taipei City, Taiwan, 2 510(k) clearances
Hjy Smart Medical Device Co., Ltd. is registered with the FDA (registration 3025341449) in Taipei City, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025341449
- Address
- 12F, No. 415, Sec. 4, Xinyi Rd., Xinyi Dist., Taipei City, Taiwan, 11051
- Owner or operator
- HJY Smart Medical Device Co., Ltd. (10086523)
- Roles
- Specification developer
- First device listed
- November 15, 2022
- Registered through
- 2026
- Brand names listed
- HDSE201, HDSES01, HHMD01, MLDLR, HSR02
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Cine, Microsurgical, With Audio | FWK | 1 | Specification developer | accessdata.fda.gov |
| Endoscope, Neurological | GWG | 2 | Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Specification developer | 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 21, 2025 | K243429 | HJY VisualNext 3D Endoscopic Vision System | GWG | Substantially Equivalent | Hjy Smart Medical Device Co., Ltd. | accessdata.fda.gov |
| July 28, 2023 | K222735 | HJY VisualNext Endoscopic Vision System | GWG | Substantially Equivalent | Hjy Smart Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 21, 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.