Elekta Solutions AB
SE-MF-000002125 · Sweden · Stockholm
Elekta Solutions AB is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 7 |
|---|---|
| Class IIb | 4 |
Most frequent device types declared: EMLA, Leksell GammaPlan, Monaco, FirmFix, Major version 8.
Among these devices, 1 are declared sterile, 3 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ELEKTA SOLUTIONS AB (SE) · FDA 3015232217 |
| Devices in EUDAMED | 11 |
| Country of registration | Sweden |