Elekta Solutions Ab
Plant certified by the Brazilian health regulator (ANVISA)
ANVISA, the Brazilian health regulator, holds a valid Good Manufacturing Practice certificate for this plant, covering medical devices (MDSAP audit programme), valid until 2028-10-29. The certificate is issued after an inspection of the plant itself, which is why a foreign regulator names this site: goods made here are allowed on the Brazilian market. The certificate records the site address as HAGAPLAN 4, 113 68, ESTOCOLMO. Process number 25351417366202441.
- Type
- brand seeking distribution
- Location
- Stockholm (Estocolmo), Sweden
- Categories
- Perlengkapan Medis & Kesehatan
- Markets
- Swedia, Brasil
Listed in a source registry
Verified facts
- fda-registered (green), checked 2026-08-24 FDA
- debarment-clear (green), checked 2026-08-24 OpenSanctions
- sanctions-clear (green), checked 2026-08-24 OpenSanctions
- public-contract-awarded (green), checked 2026-08-26 TED, EU public procurement bulletin Di sini kemenangan tender juga membawa pemeriksaan pihak lain: di UE dan EEA, pembeli publik wajib menggugurkan peserta yang dipidana karena penipuan, korupsi, atau pencucian uang, serta yang tunggakan pajak atau iurannya ditetapkan lewat putusan final. Directive 2014/24/EU, Article 57 (exclusion grounds)
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
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)