FDA Registration
Active
🇻🇳 Vietnam
REAK VIETNAM COMPANY LIMITED
Reg #: 3034205725
·
FEI: 3034205725
·
Expires 2026
Products
11
Proprietary Names
11
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- REAK VIETNAM COMPANY LIMITED
- Registration Number
- 3034205725
- FEI Number
- 3034205725
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. A2-1.F2, Road No. D3, Nhon Trach II - Loc Khang Industrial Park
- City
- Nhon Trach Commune Dong Nai
- Country
- VN
Owner / Operator
- Firm Name
- REAK VIETNAM COMPANY LIMITED
- Operator Number
- 10092253
- Address
- No. A2-1.F2, Road No. D3, Nhon Trach II - Loc Khang Industrial Park
- City
- Nhon Trach Commune
- State
- Dong Nai
- Postal Code
- 815920
- Country
- VN
US Agent
- Business Name
- Mansour Consulting LLC
- Contact Name
- Jay Mansour
- Address
- 845 Aronson Lake Ct
- City
- Roswell
- State
- GA
- ZIP
- 30075
- Country
- US
- [email protected]
- Phone
- 678 9088180
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2024-12-17 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2024-12-17 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2026-02-11 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2024-12-17 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2024-12-17 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2024-12-17 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2024-12-17 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2024-12-17 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2024-12-17 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-06-26 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-12-17 |
Proprietary Names
SUPPORT, ARM
Pack, hot or cold, reusable
Sleeve, Limb, Compressible
SPLINT, HAND, AND COMPONENTS
JOINT, KNEE, EXTERNAL BRACE
ORTHOSIS, ABDOMINAL
ORTHOSIS, LUMBAR
ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB
JOINT, HIP, EXTERNAL BRACE
Protector, skin pressure
JOINT, ANKLE, EXTERNAL BRACE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)