FDA Registration
Active
🇨🇳 China
POLYGREEN (HK) CO., LTD.
Reg #: 3001034529
·
FEI: 3001034529
·
Expires 2026
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- POLYGREEN (HK) CO., LTD.
- Registration Number
- 3001034529
- FEI Number
- 3001034529
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit01, 11/F, Block A, Mai Hing Industrial Building, 16-18 Hing Yip Street, Kwun Tong
- City
- Kowloon Hong Kong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K092806
Owner / Operator
- Firm Name
- K-JUMP HEALTH CO., LTD.
- Operator Number
- 9002077
- Address
- No. 56, Wu Kung 5th Rd., New Taipei Industrial Park
- City
- New Taipei City
- State
- TW-NOTA
- Postal Code
- 24890
- Country
- TW
- Correspondent
- Steven Lee
US Agent
- Business Name
- POLYGREEN USA LLC
- Contact Name
- Stan Cohen
- Address
- 1001 Bannock Street, Suite 308
- City
- Denver
- State
- CO
- ZIP
- 80204
- Country
- US
- [email protected]
- Phone
- 303 2710300 ext. 3
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2009-10-20 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2024-08-12 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2020-09-07 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-08 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device