Elekta
Radiation therapy and radiosurgery equipment for cancer care.
Elekta is a Swedish medical technology company manufacturing linear accelerators, Gamma Knife radiosurgery systems and oncology software used in cancer treatment centres. The company sells equipment and service contracts to hospitals and clinics in over 120 countries.
- Type
- brand seeking distribution
- Location
- Stockholm, Sweden
- Founded
- 1972
- Website
- elekta.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Sweden, United States, Germany, China
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- domain-registered (green), checked 2026-08-08 Domain registry record
- fda-registered (green), checked 2026-08-08 FDA
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)