Ceramed - Ceramicos Para Aplicações Médicas S.A
Plante certifiée par le régulateur brésilien de la santé (ANVISA)
ANVISA, le régulateur brésilien de la santé, détient un certificat de bonnes pratiques de fabrication valide pour cette usine, couvrant les dispositifs médicaux, valable jusqu'au 07/10/2026. Le certificat est délivré après une inspection de l'usine elle-même, c'est pourquoi un régulateur étranger nomme ce site : les produits fabriqués ici sont autorisés sur le marché brésilien. Le certificat enregistre l'adresse du site comme RUA JOSÉ GOMES FERREIRA, N. º 1, ARMAZÉM D, SÃO JULIÃO DO TOJAL, LOURES 2660-360. Numéro de processus 25351426377201954.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Lisboa, Portugal
- Categories
- Fournitures médicales et de santé
- Markets
- Portugal, Brésil
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)