ANVISA registration
Luminex® 100/200 Calibration Kit
Registration 80003610621. SOLUÇÃO PARA AVALIAÇÃO DE DESEMPENHO DOS COMPONENTES DE EQUIPAMENTOS
Registration details
| Registration number | 80003610621 |
|---|---|
| Application number | 25351162226202519 |
| Technical name | SOLUÇÃO PARA AVALIAÇÃO DE DESEMPENHO DOS COMPONENTES DE EQUIPAMENTOS |
| Risk class | I |
| Published on | 24/10/2025 |
| Validity | Indefinite validity |
Registration holder
| Legal name | WERFEN MEDICAL LTDA |
|---|---|
| CNPJ | 02.004.662/0001-65 |
Manufacturer
- LUMINEX CORPORATION ESTADOS UNIDOS DA AMÉRICA
Other registrations held by WERFEN MEDICAL LTDAview all
IL TESTE EMULSAO DE REFERENCIA
80003610043HEMOSIL APTT-SP
80003610045ENSAIO DE CONTROLE NORMAL DE HEMOSIL
80003610048IL TESTE PLASMA REAGENTE FATOR V RESISTENCIA DOFATOR V a APC
80003610051FAMILIA DE CONTROLES UNI OU MULTIPARÂMETROS-HEMOSIL ENSAIO DE CONTROLE ANORMAL ALTO E BAIXO - WERFEN
80003610113GEM CVP
80003610117Source: 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