Medin, A.S.
Pianta certificata dall'ente regolatore sanitario brasiliano (ANVISA)
ANVISA, l'ente regolatore sanitario brasiliano, detiene un certificato di buona pratica di fabbricazione valido per questo impianto, che copre i dispositivi medici, valido fino al 18-03-2028. Il certificato viene rilasciato dopo un'ispezione dello stabilimento stesso, motivo per cui un regolatore straniero nomina questo sito: le merci prodotte qui sono ammesse sul mercato brasiliano. Numero di processo 25351298388201723.
- Type
- brand seeking distribution
- Location
- Czechia
- Categories
- Forniture medicali e sanitarie
- Markets
- Cechia, Brasile
Listed in a source registry
Verified facts
- debarment-clear (green), checked 2026-09-02 OpenSanctions
- sanctions-clear (green), checked 2026-09-02 OpenSanctions
- listed-in-registry (green), checked 2026-09-02 BRIS, EU business registers interconnection (e-justice.europa.eu)
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
- registry-active-global (green), checked 2026-08-24 ARES (Czech business register)
- registered-since (green), checked 1992-02-26 ARES (Czech business register)
- registry-activity (green), checked 1992-02-26 ARES (Czech business register)
- facility-registered (green), checked 2026-08-30 European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
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)