LEO Medical Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 4 device types, 2 products catalogued, 2 clearances.
LEO Medical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Dilator, Esophageal, Ligator, Esophageal and 2 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2025.
4device types registered with the FDA
2products catalogued under its own name
2510(k) clearances
Registration
| Registered name | LEO MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011347300 |
| FEI number | 3011347300 |
| DUNS | 421371962 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 常州乐奥医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91320400583787801K |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Changzhou City, |
| Postal code | 213022 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Dilator, Esophageal | Class 2 | BX00718012W, KZ0630E0, KZ1055G3, KZ0855G1, KZ1055G0, KZ1280F0 and 54 more | 2025 | 9 |
| Ligator, Esophageal | Class 2 | Ligation Device, Loop20B0-LD230D0, Loop20B0-LD165D0, EN10701, Loop30B0-LD230D0, Loop30B0-LD195D0 and 8 more | 2025 | 7 |
| Ligator, Hemorrhoidal | Class 2 | Ligation Device, Loop20B0-LD230D0, Loop20B0-LD165D0, EN10701, Loop30B0-LD230D0, Loop30B0-LD195D0 and 8 more | 2025 | 12 |
| Stents, Drains And Dilators For The Biliary Ducts | Class 2 | BX00718012W, KZ0630E0, KZ1055G3, KZ0855G1, KZ1055G0, KZ1280F0 and 54 more | 2025 | 6 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Single-use Balloon Dilatation Catheter | FGE | 102 |
| Ligation Device | FHN | 12 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241888 | 2024-12-20 | FGE | Traditional | This company |
| K172985 | 2018-06-14 | FHN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Employees | 260 |
| Factory area | 7000 square meters |
| Main products | ERCP Quick Exchange System, Single-Use Electrosurgical Snare, Endoscopic Stone Retrieval Basket, Pancreatic Stent, Peripheral Metallic Stent System |
| Certifications | National High-Tech Enterprise, CE marking, Internet Pharmaceutical Information Service License |
| Export markets | 50+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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