FDA Registration
Active
🇻🇳 Vietnam
HEPTEX INDUSTRY COMPANY LIMITED
Reg #: 3015543909
·
FEI: 3015543909
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
3
Classifications
7
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Registration Details
- Registration Name
- HEPTEX INDUSTRY COMPANY LIMITED
- Registration Number
- 3015543909
- FEI Number
- 3015543909
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2187A Hung Vuong Street, Gia Cam Ward
- City
- Viet Tri Phu Tho
- Country
- VN
Owner / Operator
- Firm Name
- HEPTEX INDUSTRY COMPANY LIMITED
- Operator Number
- 10060915
- Address
- 2187A Hung Vuong Street, Gia Cam Ward
- City
- Viet Tri
- State
- Phu Tho
- Postal Code
- 29000
- Country
- VN
- Correspondent
- YC Kwok
US Agent
- Business Name
- BARBARAS DEVELOPMENT, INC.
- Contact Name
- Amy XU
- Address
- 2545 W Hillcrest Dr Ste 215
- City
- Thousand Oaks
- State
- CA
- ZIP
- 91320
- Country
- US
- [email protected]
- Phone
- 888 9025500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2019-07-12 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2019-07-12 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2021-08-11 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2025-11-25 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2019-07-12 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2019-07-12 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2019-07-12 |
Proprietary Names
ARM ELEVATOR SLING,ARM ELEVATOR STING
AC SPORT BRACE
Super Knee
ANKLE BRACES,MALLEOFORCE
BUCKS TRACTION,KNEE SLING
WRIST MANAGEMENT, SPLINT,HAND,AND COMPONENTS
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)