FDA Registration
Active
🇮🇪 Ireland
Edwards Rail Tray
Reg #: 3017298588
·
FEI: 3017298588
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Edwards Lifesciences Ireland Limited
- Registration Number
- 3017298588
- FEI Number
- 3017298588
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- National Technology Park, Castletroy
- City
- Limerick Munster
- Country
- IE
Owner / Operator
- Firm Name
- Edwards Lifesciences LLC
- Operator Number
- 9040666
- Address
- One Edwards Way
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
- Correspondent
- Denny Kouri
US Agent
- Business Name
- Edwards Lifesciences
- Contact Name
- Denny Kouri
- Address
- One Edwards Way
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
- [email protected]
- Phone
- 949 2502500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cardiovascular Delivery Catheter System Positioning And Stabilization Device | QWA | Class 1 | Cardiovascular | No | 2023-05-17 |
Proprietary Names
Edwards Rail Tray
Edwards EVOQUE Stabilizer
Edwards Reusable Rail
Edwards Reusable Rail Extension
Edwards Reusable Accessories - Reusable Cradle
Edwards Reusable Accessories - Reusable Plate
PASCAL System - Table
PASCAL System - Stabilizer Rail System
Edwards Reusable Accessories - Reusable Platform
Edwards EVOQUE Accessories
Edwards Stabilizer Rail System
Establishment Types
Manufacture Medical Device