FDA Registration
Active
🇻🇳 Vietnam
Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced)
Reg #: 3025771437
·
FEI: 3025771437
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NAM DUONG PERSONAL PROTECTIVE EQUIPMENT MANUFACTURING JOINT STOCK COMPANY
- Registration Number
- 3025771437
- FEI Number
- 3025771437
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Thai Hoa Group, Hoa Mac Ward
- City
- Duy Tien Township Ha Nam
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K190950
Owner / Operator
- Firm Name
- NAM DUONG PERSONAL PROTECTIVE EQUIPMENT MANUFACTURING JOINT
- Operator Number
- 10087062
- Address
- Thai Hoa Group,, Hoa Mac Ward,
- City
- Duy Tien Township
- State
- Ha Nam
- Postal Code
- 18000
- Country
- VN
US Agent
- Business Name
- Willow Glen Consultancy LLC
- Contact Name
- Wen Wang
- Address
- 8880 Rio San Diego Dr., #800
- City
- San Diego
- State
- CA
- ZIP
- 92108
- Country
- US
- [email protected]
- Phone
- 619 8690249
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2023-01-07 |
Proprietary Names
Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced)
Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
Medline Level 3 Surgical Gown (Sirus Fabric Reinforced)
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced)
Medline Level 3 Surgical Gown (Sirus Non-Reinforced)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)