FDA Registration
Active
🇮🇪 Ireland
APS MATERIALS INC. IRELAND
Reg #: 3007740680
·
FEI: 3007740680
·
Expires 2025
Products
8
Proprietary Names
0
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- APS MATERIALS INC. IRELAND
- Registration Number
- 3007740680
- FEI Number
- 3007740680
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 26A, Waterford Industrial Estate, Cork Road, Waterford
- City
- Waterford
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K120578
Owner / Operator
- Firm Name
- APS Materials Inc. Ireland
- Operator Number
- 10029870
- Address
- Unit 26A, Waterford Industrial Estate, Cork Road, Waterford
- City
- Waterford
- State
- IE-WD
- Postal Code
- X91F670
- Country
- IE
- Correspondent
- Caroline Butler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-11-16 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)