BIOLOGICAL HEART VALVE PROSTHESIS
ANVISA Registration Number: 80219050181EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDAEDWARDS LIFESCIENCES LLCRisk Class IV
Device names
- Technical name
- BIOLOGICAL HEART VALVE PROSTHESIS
- Commercial name
- Sistema Edwards SAPIEN 3 Ultra - Sistema de Entrega Edwards Certitude 20 mm
- Risk class
- Class IV
PT: PRÓTESE VALVULAR CARDÍACA BIOLÓGICA
Registration details
- Registration Number
- 80219050181
- Process Number
- 25351823694202059
- CNPJ
- 05944604000100
Company information
- Registration Holder
- EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA
- Manufacturer
- EDWARDS LIFESCIENCES LLC
- Manufacturing Country
- United States
PT: ESTADOS UNIDOS DA AMÉRICA
Dates and status
- Publication Date
- Apr 19, 2021
- Validity
- 19/04/2031
- Last Updated
- 08/18/2026 19:00:00
About this record
Access comprehensive regulatory information for BIOLOGICAL HEART VALVE PROSTHESIS in Brazil's medical device market through Pure Global AI's free database. This Risk Class IV medical device is registered under ANVISA number 80219050181 and manufactured by EDWARDS LIFESCIENCES LLC. The registration is held by EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA with validity until Apr 19, 2031.
This page shows the facts attached to this official registry row. Exact-name links return deterministic registry matches; open-ended comparison and market analysis are handed to AI Search with this record's context, without asserting that similar names represent the same entity.