FDA Registration
Active
🇻🇳 Vietnam
ENVIRONSTAR GROUP COMPANY LIMITED
Reg #: 3017467279
·
FEI: 3017467279
·
Expires 2026
Products
9
Proprietary Names
6
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- ENVIRONSTAR GROUP COMPANY LIMITED
- Registration Number
- 3017467279
- FEI Number
- 3017467279
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot DH 2 & V-1 Cau Nghin Industrial Zone, Phu Duc commune
- City
- Hung Yen Province
- Country
- VN
Owner / Operator
- Firm Name
- ENVIRONSTAR GROUP COMPANY LIMITED
- Operator Number
- 10076505
- Address
- Lot DH 2 and Lot V-1, Cau Nghin Industrial Zone, Phu Duc commune
- City
- Hung Yen Province
- State
- VN-NOTA
- Postal Code
- 410000
- Country
- VN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2022-11-08 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2021-08-17 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2023-03-01 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-07-21 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2021-07-02 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2024-05-20 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2021-08-17 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2022-11-08 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2022-11-08 |
Proprietary Names
Medline Brand Ultrasonic Isolation Gown
Medline Brand Clip Cap
Medline brand isolation gown
Medline brand surgical drape
Medline Brand Shoe Cover
Medline Brand Coverall , Labcoat
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device