FDA Registration
Active
🇨🇳 China
XIAMEN HUAKANG ORTHOPEDIC CO.,LTD
Reg #: 3008903689
·
FEI: 3008903689
·
Expires 2026
Products
16
Proprietary Names
16
Establishment Types
2
Classifications
16
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Registration Details
- Registration Name
- XIAMEN HUAKANG ORTHOPEDIC CO.,LTD
- Registration Number
- 3008903689
- FEI Number
- 3008903689
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2017-10-18 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2017-10-18 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2017-10-18 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-29 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2017-10-18 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2017-10-18 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-13 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2025-01-08 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2018-11-12 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2017-10-18 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2022-08-19 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2017-10-18 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2018-11-12 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2017-10-18 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-03-29 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2022-11-30 |
Proprietary Names
Limb brace
Ankle, external brace
Cervical collar
Isolation Gown
Lumbo-Sacral back brace
Shoulder/Arm Sling
Face Mask
Scoliosis Brace
elbow brace, hand braces, hip brace, foot brace
knee brace, Hand Splint
Positioning Straps
Abdominal Binder
crutches
Clavicle Splint
Goggles
Hernia truss support
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device