FDA Registration
Active
🇮🇪 Ireland
CARAGH PRECISION
Reg #: 3009173317
·
FEI: 3009173317
·
Expires 2025
Products
2
Proprietary Names
0
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- CARAGH PRECISION
- Registration Number
- 3009173317
- FEI Number
- 3009173317
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Parkmore West
- City
- Galway
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K140881
Owner / Operator
- Firm Name
- Caragh Precision
- Operator Number
- 10043503
- Address
- Parkmore West
- City
- Galway
- State
- IE-G
- Postal Code
- 9999
- Country
- IE
- Correspondent
- Edward Kenny
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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2023-11-16 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2023-11-16 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)