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 IIb | 4 |
|---|---|
| Class IIa | 7 |
Most frequent device types declared: EMLA, FirmFix, Leksell GammaPlan, Major version 8, Monaco.
Among these devices, 1 are declared sterile, 3 active.
Devices declared under this manufacturer
- Elekta Harmony
- Elekta Harmony Pro
- FirmFix 1
- Kaiku Health
- Leksell GammaPlan 11.5
- Leksell Vantage X-Ray Fiducial Box
- Leksell Vantage X-Ray Table Fixation
- Leksell Vantage X-Ray Universal Fixation
- Monaco RTP System
- Vantage Adapter for Mayfield
- Vantage Radiolucent Adapter for Doro
Catalogue references include 1040031, 1136512, 1136545, 1577756, 1578097, 1578932.
European nomenclature codes declared: Z12100601, Z11010102, Z11010782, Z11010401,Z11010492, Z12040192.
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 |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 27.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ELEKTA SOLUTIONS AB |
What it holds in Canada
| Licences on record | 21 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| Class 3 devices | 14 |
| First licensed | 1999-08-26 |
Licence types: Device Family (8), System (6), Single Device (4), Device Group Family (3).
Licensed under: ELEKTA TREATMENT TABLE, LEKSELL GAMMA KNIFE, LEKSELL GAMMAPLAN, LEKSELL STEREOTACTIC SYSTEM, MONACO RTP SYSTEM, ATLAS-BASED AUTOSEGMENTATION.
North American profile: Both markets. Elekta Solutions AB is registered in both the United States and Canada.