FDA Registration
Active
🇨🇳 China
elbow brace, hand braces, hip brace, foot brace
Reg #: 3008903689
·
FEI: 3008903689
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- XIAMEN HUAKANG ORTHOPEDIC CO.,LTD
- Registration Number
- 3008903689
- FEI Number
- 3008903689
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2F,Building #13, No. 2881 Dongfu Avenue, Haicang District
- City
- Xiamen City Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Xiamen Huakang Orthopedic Co.,Ltd
- Operator Number
- 10055922
- Address
- 2F,Building #13, No. 2881 Dongfu Avenue, Haicang District
- City
- Xiamen City
- State
- Fujian
- Postal Code
- 361027
- Country
- CN
- Correspondent
- Yong Xiao
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 |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2018-11-12 |
Proprietary Names
elbow brace, hand braces, hip brace, foot brace
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device