FDA Registration
Active
🇨🇳 China
MEDSOURCE FACTORY,INC.
Reg #: 3009512503
·
FEI: 3009512503
·
Expires 2026
Products
19
Proprietary Names
2
Establishment Types
4
Classifications
19
Registration Details
- Registration Name
- MEDSOURCE FACTORY,INC.
- Registration Number
- 3009512503
- FEI Number
- 3009512503
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.160 JIN SHENG DONG LU, JINTAN DISTRICT
- City
- CHANGZHOU Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K090014
Owner / Operator
- Firm Name
- MEDSOURCE FACTORY,INC.
- Operator Number
- 10086559
- Address
- NO.160 JIN SHENG DONG LU, JINTAN DISTRICT
- City
- CHANGZHOU
- State
- Jiangsu
- Postal Code
- 213200
- Country
- CN
- Correspondent
- LU GUOFANG
US Agent
- Business Name
- AIKEN CORP
- Contact Name
- YANG Xiangfang
- Address
- 1979 W.HOLT AVE
- City
- Pomona
- State
- CA
- ZIP
- 91768
- Country
- US
- [email protected]
- Phone
- 909 8681800
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2022-11-19 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-04-22 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2022-11-19 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2022-11-19 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2023-01-29 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2025-08-26 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2024-03-20 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2022-11-19 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2024-05-16 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2022-11-19 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2022-11-19 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2025-04-22 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2025-05-29 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2022-11-18 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2022-11-19 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2022-11-19 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2022-11-19 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2025-02-23 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2024-01-24 |
Proprietary Names
Burn Sheet
IV start kit
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Repack or Relabel Medical Device