Data / Medical devices / China / Well Lead Medical (hainan) Co., Ltd.
Well Lead Medical (hainan) Co., Ltd.: FDA-registered device maker in Haikou Hainan, China, 1 510(k) clearance
Well Lead Medical (hainan) Co., Ltd. is registered with the FDA (registration 3027301746) in Haikou Hainan, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3027301746
- Address
- No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park, 571157,Haikou, Hainan, China, Haikou Hainan, China, 570000
- Owner or operator
- Well Lead Medical (Hainan) Co., Ltd. (10087515)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 17, 2023
- Registered through
- 2027
- Brand names listed
- AMSure Red Rubber Urethral Catheter, AMSure Silicone Coated Latex Foley Catheter, Latex Foley Catheter, Wellead Latex Foley Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter, Ureteral, Gastro-Urology | EYB | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter, Urological (Antimicrobial) And Accessories | MJC | 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 |
|---|---|---|---|---|---|---|
| June 6, 2024 | K233094 | Wellead® Latex Foley Catheter | MJC | Substantially Equivalent | Well Lead Medical (Hainan) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Ureteral, Gastro-Urology
- All makers of Catheter, Retention Type, Balloon
- All makers of Catheter, Urological (Antimicrobial) And Accessories
Updated June 6, 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.