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.
ANVISA, regulador sanitario brasileño, posee para esta planta un certificado de Buenas Prácticas de Fabricación válido, que abarca dispositivos médicos (programa de auditoría MDSAP), válido hasta el 08-01-2030. El certificado se emite después de una inspección de la propia planta, razón por la cual un regulador extranjero nombra este sitio: los productos fabricados aquí están permitidos en el mercado brasileño. Número de trámite 25351839769202366.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Sweden
- Categories
- Suministros médicos y sanitarios
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 Aquí la adjudicación lleva además una comprobación ajena: en la UE y el EEE el comprador público debe excluir a los licitadores condenados por fraude, corrupción o blanqueo, y a aquellos con deudas tributarias o de cotizaciones establecidas por resolución firme. Esa comprobación valió para esa licitación en la fecha de la adjudicación: no muestra la situación actual de la empresa, y una adjudicación no muestra que el contrato se haya ejecutado. 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)