ANVISA registration

Família LumiraDx HbA1c

Registration 10287411737. HEMOGLOBINA GLICADA (HbA1C)

Registration details

Registration number10287411737
Application number25351015814202556
Technical nameHEMOGLOBINA GLICADA (HbA1C)
Risk classII
Published on05/03/2025
ValidityIndefinite validity

Registration holder

Legal nameROCHE DIAGNÓSTICA BRASIL LTDA
CNPJ30.280.358/0001-86

Manufacturer

  • LUMIRADX UK LTD REINO UNIDO

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