FDA Registration
Active
🇮🇪 Ireland
No proprietary name
Reg #: 3005581234
·
FEI: 3005581234
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Nelipak Healthcare Packaging
- Registration Number
- 3005581234
- FEI Number
- 3005581234
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KILBEGGAN ROAD
- City
- CLARA, Offaly
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K936292
Owner / Operator
- Firm Name
- Nelipak Healthcare Packaging
- Operator Number
- 9082522
- Address
- KILBEGGAN ROAD, --
- City
- CLARA, CO.OFFALY
- State
- IE-NOTA
- Postal Code
- R35 F583
- Country
- IE
- Correspondent
- Sara - Cahill
US Agent
- Business Name
- Nelipak Healthcare Packaging
- Contact Name
- Rolando Salas
- Address
- 21 Amflex Drive
- City
- Cranston
- State
- RI
- ZIP
- 02921
- Country
- US
- [email protected]
- Phone
- 401 9462699
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2006-02-02 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2006-02-02 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2006-02-02 |
Proprietary Names
No proprietary name
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)