FDA Registration
Active
🇨🇳 China
Medical Face Mask Earloop
Reg #: 3007966889
·
FEI: 3007966889
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Winner Medical (Huanggang) Co., Ltd.
- Registration Number
- 3007966889
- FEI Number
- 3007966889
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Winner Industrial Park, Te1,Chibi Road
- City
- Huanggang Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220194
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
- Correspondent
- Xiaomeng Yang
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 |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-07-15 |
Proprietary Names
Medical Face Mask Earloop
Procedure Mask
Face Mask
Medical Mask
Surgical Face Mask
Medical Face Mask
Earloops Face Mask
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)