FDA Registration
Active
🇭🇰 Hong Kong
DIRECSOURCE LIMITED
Reg #: 3016964847
·
FEI: 3016964847
·
Expires 2026
Products
13
Proprietary Names
3
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- DIRECSOURCE LIMITED
- Registration Number
- 3016964847
- FEI Number
- 3016964847
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FLAT/RM A, 12/F, ZJ 300, 300 LOCKHART ROAD, WAN CHAI
- City
- HONG KONG
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K181981
Owner / Operator
- Firm Name
- DIRECSOURCE LIMITED
- Operator Number
- 10084990
- Address
- FLAT/RM A, 12/F, ZJ 300, 300 LOCKHART ROAD, WAN CHAI
- City
- HONG KONG
- State
- HK-NOTA
- Postal Code
- 999077
- Country
- HK
- Correspondent
- Amy XU
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 |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2022-04-28 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2023-10-31 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-04-28 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2022-04-28 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2022-04-28 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2023-10-31 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-04-28 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 2022-04-26 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2024-02-26 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2022-04-28 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2022-04-28 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2022-04-28 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2022-04-28 |
Proprietary Names
Donjoy
Procare
COLLAR
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device