FDA Registration
Active
🇮🇪 Ireland
APS MATERIALS INC. IRELAND
Reg #: 3007740680
·
FEI: 3007740680
·
Expires 2026
Products
21
Proprietary Names
11
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- APS MATERIALS INC. IRELAND
- Registration Number
- 3007740680
- FEI Number
- 3007740680
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 26A, Waterford Industrial Estate, Cork Road, Waterford
- City
- Waterford
- Country
- IE
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
- John Day
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2023-10-24 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-08-19 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2011-03-02 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | 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, 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 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2013-01-10 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2013-01-10 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2013-01-10 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2023-08-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2023-11-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2023-11-16 |
Proprietary Names
INBONE TOTAL ANKLE
Comprehensive Shoulder System
Latitude EV Total Elbow Arthroplasty
Aequalis Reversed Shoulder Prosthesis
INBONE II TOTAL ANKLE REPLACEMENT
PERFORM Humeral System - Stem
Comprehensive Reverse Shoulder System
Topez Total Ankle Replacement
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
Comprehensive Reverse Shoulder
COMPREHENSIVE PRIMARY SHOULDER STEMS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)