FDA Registration
Active
🇨🇳 China
Collagen Wound Dressing
Reg #: 3031238659
·
FEI: 3031238659
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Winner Medical Co., Ltd., Shenzhen Branch
- Registration Number
- 3031238659
- FEI Number
- 3031238659
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101-104,Building A No.3 Technology Road,Zhukeng Community,Longtian Sub-district,Pingshan District, Shenzhen, Building A, Warehouse of Songze Industrial Park
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231152
Owner / Operator
- Firm Name
- WINNER MEDICAL CO., LTD.
- Operator Number
- 9012349
- Address
- 42nd Floor, Building No.2, Huilong Business Center, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
US Agent
- Business Name
- REGISTRAR CORP
- Contact Name
- DAVID LENNARZ
- Address
- 144 RESEARCH DRIVE, HAMPTON , VIRGINIA , 23666 , UNITED STATES
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2023-12-20 |
Proprietary Names
Collagen Wound Dressing
Wound Dressing With Animal-Derived Material(S)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)