FDA Registration
Active
🇬🇧 United Kingdom
ELEKTA LIMITED
Reg #: 9617016
·
FEI: 3002806900
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ELEKTA LIMITED
- Registration Number
- 9617016
- FEI Number
- 3002806900
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Cornerstone, London Road
- City
- CRAWLEY West Sussex
- Country
- GB
Owner / Operator
- Firm Name
- ELEKTA AB
- Operator Number
- 8030893
- Address
- Hagaplan 4
- City
- Stockholm
- State
- SE-AB
- Postal Code
- SE11368
- Country
- SE
US Agent
- Business Name
- Elekta
- Contact Name
- Thomas Valentine
- Address
- 400 Perimeter Center Terrace, Suite 50
- City
- ATL
- State
- GA
- ZIP
- 30346
- Country
- US
- [email protected]
- Phone
- 404 7972537
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2023-03-02 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2023-03-02 |
| System, Simulation, Radiation Therapy | KPQ | Class 2 | Radiology | No | 2023-07-13 |
| System, Radiation Therapy, Radionuclide | IWB | Class 2 | Radiology | No | 2023-07-13 |
Proprietary Names
Elekta Unity MR Linac
Elekta Synergy, Elekta Infinity, Versa HD, Elekta Harmony/Harmony Pro
Clarity System
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elek
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)