FDA Registration
Active
🇮🇪 Ireland
HidraWear AX GAX001_GAX002
Reg #: 3016629854
·
FEI: 3016629854
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- HIDRAMED SOLUTIONS LIMITED
- Registration Number
- 3016629854
- FEI Number
- 3016629854
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 209 Business Innovation Centre, NUI Galway
- City
- Galway
- Country
- IE
Owner / Operator
- Firm Name
- HidraMed Solutions Limited
- Operator Number
- 10062420
- Address
- Business Innovation Centre, NUI Galway
- City
- Galway
- State
- IE-G
- Postal Code
- H91V207
- Country
- IE
- Correspondent
- Conan Cavanagh
US Agent
- Business Name
- Willow Glen Consultancy LLC
- Contact Name
- Wen Wang
- Address
- 8880 Rio San Diego Drive, #800
- City
- San Diego
- State
- CA
- ZIP
- 92108
- Country
- US
- [email protected]
- Phone
- 619 8690249
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2020-02-06 |
Proprietary Names
HidraWear AX GAX001_GAX002
HidraWear BB GBB001_GBB002
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198