Elekta
Equipos de radioterapia y radiocirugía para la atención del cáncer.
Elekta es una empresa sueca de tecnología médica que fabrica aceleradores lineales, sistemas de radiocirugía Gamma Knife y software de oncología utilizados en centros de tratamiento del cáncer. La empresa vende equipos y contratos de servicios a hospitales y clínicas en más de 120 países.
- Type
- brand seeking distribution
- Location
- Stockholm, Sweden
- Founded
- 1972
- Website
- elekta.com
- Categories
- Suministros médicos y sanitarios
- Markets
- Suecia, Estados Unidos, Alemania, 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)