Data / Medical devices / China / Leo Medical Co., Ltd.
Leo Medical Co., Ltd.: FDA-registered device maker in Changzhou Jiangsu, China, 2 510(k) clearances
Leo Medical Co., Ltd. is registered with the FDA (registration 3011347300) in Changzhou Jiangsu, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011347300
- Address
- No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Changzhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA, Changzhou Jiangsu, China, 213022
- Owner or operator
- Leo Medical Co., Ltd. (10092699)
- Roles
- Manufacturer
- First device listed
- February 6, 2025
- Registered through
- 2026
- Brand names listed
- BX00715506, BX00715506W, BX00715508, BX00715508W, BX00715510, BX00715510W, BX00715512, BX00715512W and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Esophageal | KNQ | 2 | Manufacturer | accessdata.fda.gov |
| Ligator, Esophageal | MND | 2 | Manufacturer | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 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 |
|---|---|---|---|---|---|---|
| December 20, 2024 | K241888 | Single-use Balloon Dilatation Catheter | FGE | Substantially Equivalent | Leo Medical Co., Ltd. | accessdata.fda.gov |
| June 14, 2018 | K172985 | Ligation Device | FHN | Substantially Equivalent | Leo Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Esophageal
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Ligator, Esophageal
- All makers of Ligator, Hemorrhoidal
Updated December 20, 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.