Atos Medical 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.
브라질 보건 규제 기관인 ANVISA는 2030년 1월 8일까지 유효한 의료 기기(MDSAP 감사 프로그램)에 대해 이 공장에 대해 유효한 우수 제조 관리 기준 인증서를 보유하고 있습니다. 인증서는 공장 자체를 검사한 후에 발급되므로 외국 규제 기관에서 이 사이트를 명명합니다. 여기서 생산된 제품은 브라질 시장에서 허용됩니다. 프로세스 번호 25351839769202366.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Sweden
- Categories
- 의료 및 건강 관리 용품
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 5 official records from 5 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
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-24. OpenSanctions
- 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
- 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
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 8 medical devices: ProTrach Dualcare (K151404, 2016-02-12), PROVOX FREEHANDS FLEXIVOICE (K141380, 2014-09-26), PROVOX VEGA PUNCTURE SET (K131947, 2013-10-18) +5. 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)
- 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)
- 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 여기서 낙찰은 남이 한 심사까지 함께 뜻합니다. EU와 EEA에서는 공공 발주자가 사기, 부패, 자금세탁으로 유죄가 확정된 입찰자와 최종 결정으로 세금 또는 사회보험료 체납이 확인된 입찰자를 반드시 배제해야 합니다. 이 심사는 해당 입찰의 낙찰일 기준입니다. 회사의 현재 상황을 보여 주지 않으며, 낙찰이 계약 이행을 보여 주지도 않습니다. Directive 2014/24/EU, Article 57 (exclusion grounds)
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)