Pure Global AI
ANVISA registration 80219050197Valid until Dec 01, 2035

BIOLOGICAL HEART VALVE PROSTHESIS

ANVISA Registration Number: 80219050197EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDAEDWARDS LIFESCIENCES LLC (IRVINE, CA)Risk Class IV
Verified
Device names
Technical name
BIOLOGICAL HEART VALVE PROSTHESIS
View exact technical-name matches →
PT: PRÓTESE VALVULAR CARDÍACA BIOLÓGICA
Commercial name
EVOQUE Tricuspid Valve Replacement System
View exact commercial-name matches →
Risk class
Class IV
Registration details
Registration Number
80219050197
Process Number
25351020455202559
CNPJ
05944604000100
Company information
Registration Holder
EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA
Manufacturer
EDWARDS LIFESCIENCES LLC (IRVINE, CA)
Manufacturing Country
United States
PT: ESTADOS UNIDOS DA AMÉRICA
Dates and status
Publication Date
Dec 01, 2025
Validity
01/12/2035
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 80219050197 and manufactured by EDWARDS LIFESCIENCES LLC (IRVINE, CA). The registration is held by EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA with validity until Dec 01, 2035.

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.