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
- اللوازم الطبية والرعاية الصحية
- Markets
- السويد, البرازيل
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 هنا يحمل الفوز بالعقد فحصًا أجراه طرف آخر أيضًا: في الاتحاد الأوروبي والمنطقة الاقتصادية الأوروبية يجب على المشتري العام استبعاد مقدّمي العروض المدانين بالاحتيال أو الفساد أو غسل الأموال، ومن ثبتت عليهم بقرار نهائي متأخرات ضريبية أو اشتراكات اجتماعية. 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)