FDA Registration
Active
🇭🇰 Hong Kong
Globalcare Medical Technology HK, Ltd.
Reg #: 3010205626
·
FEI: 3010205626
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Globalcare Medical Technology HK, Ltd.
- Registration Number
- 3010205626
- FEI Number
- 3010205626
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room25 4/F, Tung Hip Commercial Building 244 Des Voeux Rd Central, Sheung Wan, Hong Kong
- City
- Hong Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K172842
Owner / Operator
- Firm Name
- Globalcare Medical Technology HK, Ltd.
- Operator Number
- 10046453
- Address
- Room25 4/F, Tung Hip Commercial Building 244 Des Voeux Rd Central, Sheung Wan, Hong Kong
- City
- Hong Kong
- State
- HK-NOTA
- Postal Code
- 999077
- Country
- HK
- Correspondent
- Cherry Feng
US Agent
- Business Name
- Project Marketing
- Contact Name
- Terrence O'Brien
- Address
- 2555 Kylewynd Pl
- City
- New Hill
- State
- NC
- ZIP
- 27562
- Country
- US
- [email protected]
- Phone
- 919 6231053
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2018-10-31 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2020-10-18 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2014-03-24 |
| Lung Sound Monitor | OCR | Class 2 | Cardiovascular | No | 2023-06-14 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-10-28 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-06-18 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device