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
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
- Markets
- स्वीडन, ब्राज़ील
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 यहाँ ठेका मिलना किसी और की जाँच भी साथ लाता है: यूरोपीय संघ और ईईए में सार्वजनिक क्रेता को धोखाधड़ी, भ्रष्टाचार या धनशोधन में दोषी बोलीदाताओं को, और अंतिम निर्णय से कर या सामाजिक अंशदान बकाया पाए गए बोलीदाताओं को बाहर करना अनिवार्य है। 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)