Breas Medical 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 2029-11-20. 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. Process number 25351701527202309.
- Type
- brand seeking distribution
- Location
- Sweden
- Categories
- Tıbbi ve Sağlık Malzemeleri
- Markets
- İsveç, Brezilya
Listed in a source registry
Verified facts
- debarment-clear (green), checked 2026-08-24 OpenSanctions
- fda-registered (green), checked 2026-08-24 FDA
- sanctions-clear (green), checked 2026-08-24 OpenSanctions
- 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
- public-contract-awarded (green), checked 2026-08-26 TED, EU public procurement bulletin Burada ihalenin kazanılması başkasının yaptığı bir denetimi de taşır: AB ve AEA'da kamu alıcısı, dolandırıcılık, yolsuzluk veya kara para aklamadan hüküm giymiş istekliler ile kesinleşmiş kararla vergi veya sosyal güvenlik borcu saptananları elemek zorundadır. 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)