FDA Registration
Active
🇨🇳 China
Tennis Elbow Support: Elbow Brace: Adjustable Elbow race: Arm Band Elbow Protector; Elbow Sleeve; Arm Support,
Reg #: 3013856565
·
FEI: 3013856565
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD
- Registration Number
- 3013856565
- FEI Number
- 3013856565
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1000 meters South of Dadi Town Government, Dadi village, Dadi Town, Shenzhou City
- City
- Hengshui Hebei
- Country
- CN
Owner / Operator
- Firm Name
- Hengshui Gangsheng Medical Instruments Co., Ltd
- Operator Number
- 10056289
- Address
- 1000 meters South of Dadi Town Government, Dadi village, Dadi Town, Shenzhou City
- City
- Hengshui
- State
- Hebei
- Postal Code
- 053800
- Country
- CN
- Correspondent
- XinYing Liu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2023-11-09 |
Proprietary Names
Tennis Elbow Support: Elbow Brace: Adjustable Elbow race: Arm Band Elbow Protector; Elbow Sleeve; Arm Support,
Arm Abduction, Shoulder Abduction, Arm Shoulder Abduction Brace, Shoulder Sling (Forearm sling)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device