FDA Registration
Active
🇮🇪 Ireland
PHENOX LIMITED
Reg #: 3013656790
·
FEI: 3013656790
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- PHENOX LIMITED
- Registration Number
- 3013656790
- FEI Number
- 3013656790
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kamrick Court, Ballybrit Business Park
- City
- Galway
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K221279
Owner / Operator
- Firm Name
- phenox Limited
- Operator Number
- 10061667
- Address
- Kamrick Court, Ballybrit Business Park
- City
- Galway
- State
- IE-G
- Postal Code
- H91XY38
- Country
- IE
- Correspondent
- Gary Brogan
US Agent
- Business Name
- phenox INC
- Contact Name
- Maria Little
- Address
- 9842 Research Drive, Irvine
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 844 6743669
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2023-01-06 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2023-01-06 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2026-02-05 |
| Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | POL | Class 2 | Neurology | No | 2023-11-09 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2019-11-07 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2019-11-07 |
Proprietary Names
pNOVUS 21 Microcatheter
Esperance pHLO Aspiration System
pRESET LITE Thrombectomy Device
pRESET Thrombectomy Device
pORTAL Steerable Hydrophilic Guidewire
pRESET Delta LITE Thrombectomy Device
pRESET Delta Thrombectomy Device
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198