Winner Medical (Hunan) Co., Ltd.
Registered establishment in Changde, Hunan, China. 5 device types.
Winner Medical (Hunan) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Parenteral Administration Kit, Needle, Hypodermic, Single Lumen and 3 other device types. Its earliest product listing with the FDA dates from 2026.
Registration
| Registered name | WINNER MEDICAL (HUNAN) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3047706961 |
| FEI number | 3047706961 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Location
| City | Changde |
|---|---|
| Province | Hunan |
| Address | No. 8 Industry AVE, Economic Development Zone |
| Postal code | 415500 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | Class 1 | 2026 | 37 |
| Needle, Hypodermic, Single Lumen | Class 2 | 2026 | 71 |
| Parenteral Administration Kit | Class 2 | 2026 | 5 |
| Set, Administration, Intravascular | Class 2 | 2026 | 49 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | 2026 | 23 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Employees | 1200 |
| Factory area | 180,000 square meters |
| Main products | Infusion/Transfusion sets, Injection puncture devices, Blood test devices, Medical polymer products, Sanitary protection products |
| Certifications | ISO13485, CE, FDA |
| Export markets | International |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Hunan Pinliu Biological Technology Co., Ltd. | 4 |
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.
The manufacturer named here can complete this record.