Data / Medical devices / China / Guangdong Yuxiang Silicone & Plastic Co.,ltd
Guangdong Yuxiang Silicone & Plastic Co.,ltd: FDA-registered device maker in Zhongshan Guangdong, China, 3 510(k) clearances
Guangdong Yuxiang Silicone & Plastic Co.,ltd is registered with the FDA (registration 3038319740) in Zhongshan Guangdong, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 14, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3038319740
- Address
- 4th Floor of Building 1,1st Floor to 4th Floor of Building 2 No.8,Kejian Street,Fusha Town, Zhongshan Guangdong, China, 528400
- Owner or operator
- GuangDong YuXiang Silicone & Plastic Co.,Ltd (10093352)
- Roles
- Manufacturer
- First device listed
- May 5, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Vaginal | HDX | 2 | Manufacturer | accessdata.fda.gov |
| Perineometer | HIR | 2 | 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 |
|---|---|---|---|---|---|---|
| August 14, 2024 | K241748 | Intimate Rose Vaginal Dilators | HDX | Substantially Equivalent | Plus EV Holdings Dba Intimate Rose | accessdata.fda.gov |
| June 7, 2023 | K231430 | Intimate Rose Vaginal Dilators | HDX | Substantially Equivalent | Plus EV Holdings Dba Intimate Rose | accessdata.fda.gov |
| August 24, 2020 | K193364 | Intimate Rose Kegel Exercise System | HIR | Substantially Equivalent | Plus EV Holdings Dba Intimate Rose | accessdata.fda.gov |
Compare with other makers
Updated August 14, 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.