FDA Registration
Active
🇭🇰 Hong Kong
GA HEALTH COMPANY LIMITED
Reg #: 3014749926
·
FEI: 3014749926
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- GA HEALTH COMPANY LIMITED
- Registration Number
- 3014749926
- FEI Number
- 3014749926
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 1511-13 & 15, 15/F, Tower 2, Grand Central Plaza, 138 Shatin Rural Committee Road, Shatin, N.T.
- City
- Hong Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K182998
Owner / Operator
- Firm Name
- GA Health Company Limited
- Operator Number
- 10061258
- Address
- Unit 1511-13 & 15, 15/F, Tower 2, Grand Central Plaza,, 138 Shatin Rural Committee Road, Shatin, N.T.
- City
- Hong Kong
- State
- HK-NOTA
- Postal Code
- None
- Country
- HK
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2019-10-08 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198