ANVISA registration

AFFINITY FUSION (BALANCE) - OXIGENADOR COM FILTRO ARTERIAL INTEGRADO E RESERVATÓRIO VENOSO DE CARDIOTOMIA

Registration 10349000710. Oxigenadores

Registration details

Registration number10349000710
Application number25351482099201915
Technical nameOxigenadores
Risk classII
Published on09/09/2019
ValidityIndefinite validity

Registration holder

Legal nameAUTO SUTURE DO BRASIL LTDA.
CNPJ01.645.409/0001-28

Manufacturing sites

  • MEDTRONIC MEXICO, S. DE R.L. DE CV MÉXICO
  • MEDTRONIC PERFUSION SYSTEMS ESTADOS UNIDOS DA AMÉRICA
  • MEDTRONIC, INC. ESTADOS UNIDOS DA AMÉRICA

Other registrations held by AUTO SUTURE DO BRASIL LTDA.view all

VERSAPORT CÂNULA E TROCARTE DESCARTÁVEL AUTO SUTURE

10349000004

BLUNTPORT TROCARTE DESCARTAVEL PARA LAPAROSCOPIA AUTO SUTURE

10349000006

SURGIWAND II DISPOSITIVO DE IRRIGAÇÃO DESCARTÁVEL

10349000009

ENDO RETRACT II INSTRUMENTO DESCARTAVEL AUTOSUTURE

10349000010

THORACOPORT CANULA E TROCARTE DESCARTAVEL AUTOSUTURE

10349000014

Surgineedle Agulha Descartável para Pneumoperitôneo Auto Suture

10349000017

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