GuangDong Youkey Medical Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3025429169
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What GuangDong Youkey Medical Co., Ltd. makes
GuangDong Youkey Medical Co., Ltd. manufactures diagnostic imaging devices, including a digital ultrasonic diagnostic imaging system (Model: F6) and a portable pocket ultrasound system. These products are designed for real-time internal imaging to support clinical diagnostics.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) premarket notification process. The manufacturer operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Pocket Ultrasound System Ref K211746
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3025429169
- DUNS number
- 714951617
- Address
- Unit 601, Block B, Building 1, B1 District, Hantian Technology City, Nanhai District, Foshan Guangdong
Frequently asked questions
How many devices does GuangDong Youkey Medical Co., Ltd. have in the registry?
The registry currently lists 9 devices for GuangDong Youkey Medical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GuangDong Youkey Medical Co., Ltd.'s devices?
Among its 9 most recently registered devices, GuangDong Youkey Medical Co., Ltd. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GuangDong Youkey Medical Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for GuangDong Youkey Medical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from GuangDong Youkey Medical Co., Ltd. in the registry?
The most recently registered devices listed for GuangDong Youkey Medical Co., Ltd. include NA P56, NA P55, NA P54 and NA P51.