Data / Medical devices / China / Guangdong Youkey Medical Co., Ltd.
Guangdong Youkey Medical Co., Ltd.: FDA-registered device maker in Foshan Guangdong, China, 2 510(k) clearances
Guangdong Youkey Medical Co., Ltd. is registered with the FDA (registration 3025429169) in Foshan Guangdong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3025429169
- Address
- Unit 601, Block B, Building 1, B1 District, Hantian Technology City, Nanhai District, Foshan Guangdong, China, 528203
- Owner or operator
- GuangDong Youkey Medical Co., Ltd. (10086505)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 15, 2022
- Registered through
- 2026
- Brand names listed
- Digital Ultrasonic Diagnostic Imaging System (Model: F6), Pocket Ultrasound System (model: P50, P51, P52, P53, P54, P55, P56)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, 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 22, 2024 | K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6) | IYN | Substantially Equivalent | Guangdong Youkey Medical Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K211746 | Pocket Ultrasound System | IYN | Substantially Equivalent | Guangdong Youkey Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated March 22, 2024. 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.