Elekta Solutions Ab
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
ANVISA, le régulateur brésilien de la santé, détient un certificat de bonnes pratiques de fabrication valide pour cette usine, couvrant les dispositifs médicaux (programme d'audit MDSAP), valable jusqu'au 2028-10-29. Le certificat est délivré après une inspection de l'usine elle-même, c'est pourquoi un régulateur étranger nomme ce site : les produits fabriqués ici sont autorisés sur le marché brésilien. Le certificat enregistre l'adresse du site comme HAGAPLAN 4, 113 68, ESTOCOLMO. Numéro de processus 25351417366202441.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Stockholm (Estocolmo), Sweden
- Categories
- Fournitures médicales et de santé
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 9 official records from 9 official sources are on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-24. FDA
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-08-24. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-08-24. OpenSanctions
- Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-09-07. GLEIF global LEI register (golden copy)
- Street address on file in the state register (record type: registered-address) [official record; status green] Registered address: Hagaplan 4, STOCKHOLM, 11368. The address the company itself gave the register, so post and inspectors reach it there. checked 2026-10-16. Bolagsverket, vardefulla datamangder (bulkfil)
- Trade role recorded in the register (record type: registered-trade-role) [official record; status green] The state register itself records whether the company sells wholesale, retails, or acts as an agent - not a claim the company made about itself. checked 2026-10-16. Statistikmyndigheten SCB via Bolagsverket, vardefulla datamangder
- Takes part in public tenders (record type: public-contract-awarded) [official record; status green] A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2026-09-12. TED, EU public procurement bulletin Ici l'attribution porte aussi un contrôle fait par d'autres: dans l'UE et l'EEE, l'acheteur public doit exclure les candidats condamnés pour fraude, corruption ou blanchiment, ainsi que ceux dont une décision définitive a établi des dettes fiscales ou sociales. Ce contrôle valait pour cette procédure à la date de l'attribution: il ne montre pas la situation actuelle de l'entreprise, et une attribution ne montre pas que le marché a été exécuté. Directive 2014/24/EU, Article 57 (exclusion grounds)
- manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-17. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 15 medical devices: Leksell® Vantage Stereotactic System (K261932, 2026-08-05), Monaco RTP System (6.3) (K252002, 2026-02-19), EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188, 2026-01-15) +12. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record
Relationships
1 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Recorded in a source
- HAGAPLAN 4, 113 68, ESTOCOLMO: Manufactures at the site. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
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)