ANVISA registration 80219050198Valid until Dec 01, 2035BIOLOGICAL HEART VALVE PROSTHESIS
ANVISA Registration Number: 80219050198EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDAEDWARDS LIFESCIENCES LLC (IRVINE, CA)Risk Class IV
Device names
- Technical name
- BIOLOGICAL HEART VALVE PROSTHESIS
- Commercial name
- Edwards EVOQUE Tricuspid Valve Replacement System
- Risk class
- Class IV
PT: PRÓTESE VALVULAR CARDÍACA BIOLÓGICA
Registration details
- Registration Number
- 80219050198
- Process Number
- 25351027452202546
- 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 80219050198 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.
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