FDA Registration
Active
🇨🇳 China
KANGFU MEDICAL EQUIPMENT FACTORY
Reg #: 3015140207
·
FEI: 3015140207
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- KANGFU MEDICAL EQUIPMENT FACTORY
- Registration Number
- 3015140207
- FEI Number
- 3015140207
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.380 Ningkang East Road, Yueqing
- City
- Wenzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201600
Owner / Operator
- Firm Name
- Kangfu Medical Equipment Factory
- Operator Number
- 10059139
- Address
- No.380 Ningkang East Road, Yueqing
- City
- Wenzhou
- State
- Zhejiang
- Postal Code
- 325600
- Country
- CN
- Correspondent
- Anthony Pan
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 |
|---|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-04 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2025-01-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-03-16 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2025-01-09 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2025-01-09 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2025-01-09 |
Proprietary Names
KFT-16 KFT-17 KFT-18 KFT-22 KFT-22M KFT-23 KFT- 24 KFT-25 KFT-26 KFT-27 KFT-28
KFT-01 KFT-02 KFT-03 KFT-03C KFT-04 KFT-05 KFT-05L KFT-06 KFT-07 KFT-08 KFT-09 KFT-10 KFT-11 KFT-12 KFT-13 KFT-14 KFT-15
Hearing Aid, Air-Conduction, Prescription
Hearing Aid, Air-Conduction with Wireless Technology, Prescription
Hearing Aid, Air-Conduction, Over the Counter
COCET Digital Thermometer
COCET
Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device