Magle Chemoswed Ab
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 12-05-2027. 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. Il certificato registra l'indirizzo del sito come AGNESLUNDSVAGEN 27,212, 15 MALMO. Numero di processo 25351135200202417.
- Type
- brand seeking distribution
- Location
- Malmö, Sweden
- Categories
- Forniture medicali e sanitarie
- Markets
- Svezia, Brasile
Listed in a source registry
Verified facts
- debarment-clear (green), checked 2026-08-24 OpenSanctions
- 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
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- facility-registered (green), checked 2026-08-30 European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- operating-permit (green), checked 2026-08-08 EEA Industrial Emissions Portal (IED), EU-wide permit register
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)