ANVISA registration
Edwards SAPIEN 3 - Edwards Commander System / Edwards SAPIEN 3 - Sistema Commander Edwards
Registration 80219050159. PRÓTESE VALVULAR CARDÍACA BIOLÓGICA
Registration details
| Registration number | 80219050159 |
|---|---|
| Application number | 25351232913201542 |
| Technical name | PRÓTESE VALVULAR CARDÍACA BIOLÓGICA |
| Risk class | IV |
| Published on | 10/02/2016 |
| Validity | Valid until 10/02/2036 |
Registration holder
| Legal name | EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA |
|---|---|
| CNPJ | 05.944.604/0001-00 |
Manufacturer
- EDWARDS LIFESCIENCES LLC (IRVINE, CA) ESTADOS UNIDOS DA AMÉRICA
Other registrations held by EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDAview all
GARRA ATRAUMATICA PARA OCLUSAO CIRURGICA EDWARDS
80219050001CATETER FOGARTY PARA ATRIOSEPTOSTOMIA EDWARDS
80219050002CATETER FOGARTY PARA PROVAS BILIARES EDWARDS
80219050005CO-SET + SISTEMA FECHADO PARA INFUSAO DE INJETADO FRIO
80219050011CÂNULA DE ACESSO FEMORAL
80219050017CATETER FOGARTY PARA EMBOLECTOMIA ARTERIAL EDWARDS
80219050028Source: ANVISA open data, medical device file, updated daily. The public database provides registration validity, rather than registration status: this registration may have been cancelled before its expiry date without this being shown here. Before making purchasing, import or marketing decisions, check the ANVISA search portal.
Next step
Medical device registration with ANVISA
HSC manages the process from risk classification to liaising with the regulator, in Brazil and more than 40 other countries.
Speak to a specialist