ANVISA registration

Família QUANTA Flash Ro52

Registration 80003610567. ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)

Registration details

Registration number80003610567
Application number25351856785201856
Technical nameANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Risk classII
Published on18/03/2019
ValidityIndefinite validity

Registration holder

Legal nameWERFEN MEDICAL LTDA
CNPJ02.004.662/0001-65

Manufacturer

  • INOVA DIAGNOSTICS, INC ESTADOS UNIDOS DA AMÉRICA

Source: ANVISA

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