ANVISA registration
AMVIA SKY SR-T - Marcapasso Cardíaco Implantável de Câmara Única para Estimulação Fisiológica, Condicional para Ressonância Magnética (Fullbody) com CLS
Registration 80224390312. MARCA-PASSO CARDÍACO IMPLANTÁVEL DE CÂMARA ÚNICA, COM RESPOSTA DE FREQUÊNCIA
Registration details
| Registration number | 80224390312 |
|---|---|
| Application number | 25351746340202326 |
| Technical name | MARCA-PASSO CARDÍACO IMPLANTÁVEL DE CÂMARA ÚNICA, COM RESPOSTA DE FREQUÊNCIA |
| Risk class | IV |
| Published on | 08/01/2024 |
| Validity | Valid until 08/01/2034 |
Registration holder
| Legal name | BIOTRONIK COMERCIAL MÉDICA LTDA. |
|---|---|
| CNPJ | 50.595.271/0001-05 |
Manufacturer
- BIOTRONIK SE & CO KG ALEMANHA
Other registrations held by BIOTRONIK COMERCIAL MÉDICA LTDA.view all
Source: 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