FDA Registration
Active
🇮🇪 Ireland
SMITHSTOWN LIGHT ENGINEERING
Reg #: 3001284227
·
FEI: 3001284227
·
Expires 2026
Products
12
Proprietary Names
3
Establishment Types
1
Classifications
12
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Registration Details
- Registration Name
- SMITHSTOWN LIGHT ENGINEERING
- Registration Number
- 3001284227
- FEI Number
- 3001284227
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bay H1A,, Smithstown Industrial Estate,
- City
- Shannon Clare
- Country
- IE
Owner / Operator
- Firm Name
- Smithstown Light Engineering
- Operator Number
- 10043193
- Address
- Smithstown industrial estate, Smithstown Industrial Estate,
- City
- Shannon
- State
- Clare
- Postal Code
- V14 W594
- Country
- IE
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2013-12-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-12-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-12-04 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2013-12-04 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-12-04 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2023-03-15 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-01-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-30 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2023-02-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-03-15 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2015-04-07 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-03-15 |
Proprietary Names
Anato¿ Hip System Instrumentation
Mako Total Knee Application (3); Hybrid Tip Pointer
Mako Shoulder Application (1)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)