Ceramed - Ceramicos Para Aplicações Médicas S.A
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 07-10-2026. 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 RUA JOSÉ GOMES FERREIRA, N. º 1, ARMAZÉM D, SÃO JULIÃO DO TOJAL, LOURES 2660-360. Numero di processo 25351426377201954.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Lisboa, Portugal
- Categories
- Forniture medicali e sanitarie
- Markets
- Portogallo, Brasile
Listed in a source registry
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- sanctions-clear (green), checked 2026-08-24 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- debarment-clear (green), checked 2026-08-24 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
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)