Hjy Smart Medical Device Co., Ltd.
TaiwanFDA applicant, unverified FDA FEI 3025341449
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Hjy Smart Medical Device Co., Ltd. makes
Hjy Smart Medical Device Co., Ltd. manufactures endoscopic vision systems, including a standard 2D model and a 3D variant designed for enhanced surgical visualization. These systems are intended for use in minimally invasive procedures, providing real-time imaging for improved precision during endoscopic surgeries.
The company’s portfolio is regulated under FDA Class II devices, with products listed via the 510(k) clearance pathway. The systems are based in the United States and comply with applicable U.S. medical device regulations.
Catalogue
HJY VisualNext Endoscopic Vision System Ref K222735
Regimes: 510(k) Registry: 510(k)HJY VisualNext 3D Endoscopic Vision System Ref K243429
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3025341449
- Address
- 12F, No. 415, Sec. 4, Xinyi Rd., Xinyi Dist., Taipei City
Frequently asked questions
How many devices does Hjy Smart Medical Device Co., Ltd. have in the registry?
The registry currently lists 2 devices for Hjy Smart Medical Device Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hjy Smart Medical Device Co., Ltd.'s devices?
Among its 2 most recently registered devices, Hjy Smart Medical Device Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hjy Smart Medical Device Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hjy Smart Medical Device Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hjy Smart Medical Device Co., Ltd. in the registry?
The most recently registered devices listed for Hjy Smart Medical Device Co., Ltd. include HJY VisualNext Endoscopic Vision System and HJY VisualNext 3D Endoscopic Vision System.