FDA Registration
Active
🇮🇪 Ireland
SMITHSTOWN LIGHT ENGINEERING
Reg #: 3001284227
·
FEI: 3001284227
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMITHSTOWN LIGHT ENGINEERING
- Registration Number
- 3001284227
- FEI Number
- 3001284227
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bay H1A,, Smithstown Industrial Estate,
- City
- Shannon Clare
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K223528
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, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2023-02-21 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)