ANVISA registration

FREESTYLE OPTIUM NEO H BLOOD GLUCOSE AND KETONE MONITORING SYSTEM / FREESTYLE OPTIUM NEO H SISTEMA DE MONITORAÇÃO DE GLICOSE E CETONA NO SANGUE

Registration 80146501883. INSTRUMENTO PARA GLICOSE E CORPOS CETÔNICOS POINT OF CARE TESTING (PROFISSIONAL)

Registration details

Registration number80146501883
Application number25351703307201394
Technical nameINSTRUMENTO PARA GLICOSE E CORPOS CETÔNICOS POINT OF CARE TESTING (PROFISSIONAL)
Risk classII
Published on07/07/2014
ValidityIndefinite validity

Registration holder

Legal nameABBOTT LABORATORIOS DO BRASIL LTDA
CNPJ56.998.701/0001-16

Manufacturer

  • ABBOTT DIABETES CARE 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