Data / Medical devices / China / Shaoguan Regenex Pharmaceutical Co., Ltd.
Shaoguan Regenex Pharmaceutical Co., Ltd.: FDA-registered device maker in Shaoguan Guangdong, China, 1 510(k) clearance
Shaoguan Regenex Pharmaceutical Co., Ltd. is registered with the FDA (registration 3042262517) in Shaoguan Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 11, 2025. 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
- 3042262517
- Address
- No.9, Gantang Ninth Road, Gantang Avenue, Wujiang District, Shaoguan Guangdong, China, 512029
- Owner or operator
- Shaoguan Regenex Pharmaceutical Co., Ltd. (10094273)
- Roles
- Manufacturer
- First device listed
- November 20, 2025
- Registered through
- 2026
- Brand names listed
- Natural Rubber Latex Male Condom
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 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 |
|---|---|---|---|---|---|---|
| July 11, 2025 | K250034 | Natural rubber latex male condom | HIS | Substantially Equivalent | Shaoguan Regenex Pharmaceuticals Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 11, 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.