FDA Registration
Active
🇭🇰 Hong Kong
KENPAX INTERNATIONAL LIMITED
Reg #: 3015820879
·
FEI: 3015820879
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- KENPAX INTERNATIONAL LIMITED
- Registration Number
- 3015820879
- FEI Number
- 3015820879
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Flat 5, 5/F., Wing On Plaza, 62 Mody Road, Tsim Sha Tsui
- City
- Kowloon
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K202899
Owner / Operator
- Firm Name
- Kenpax International Limited
- Operator Number
- 10062935
- Address
- Flat 5, 5/F., Wing On Plaza, 62 Mody Road, Tsim Sha Tsui
- City
- Kowloon
- State
- HK-NOTA
- Postal Code
- 999077
- Country
- HK
- Correspondent
- Scott Sun
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-05-24 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2022-12-29 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-13 |
| Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | QPC | Class 2 | General, Plastic Surgery | No | 2023-08-08 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2023-03-24 |
Proprietary Names
Isolation Gown AAMI Level 3
PE Film Gown
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device