IVD software

ANVISA technical name: SOFTWARE IVD

Tick holders, manufacturers or countries below to filter this page.

18registrations
18currently valid
13registration holders
14manufacturers
8countries
I, II, IIIrisk classes

Top registration holders

  • · latest 2026↗ 3
  • · latest 2026↗ 2
  • · latest 2026↗ 2
  • · latest 2026↗ 2
  • · latest 2026↗ 1
  • · latest 2025↗ 1
  • · latest 2025↗ 1
  • · latest 2026↗ 1
  • · latest 2024↗ 1
  • · latest 2025↗ 1

Top manufacturers

  • · United States↗ 3
  • · China↗ 2
  • · China↗ 2
  • · Israel↗ 1
  • · United States↗ 1
  • · United States↗ 1
  • · Germany↗ 1
  • · Switzerland↗ 1
  • · Italy↗ 1
  • · China↗ 1

Countries of manufacture

Related device types

All registrations

ProductClass HolderPublishedStatus
iCan Review
81464750222
I Domo Salute Consultoria Regulatória Ltda 10/08/2026 Valid
APERIO HALO AP
10337990059
II LEICA DO BRASIL IMPORTAÇÃO E COMÉRCIO LTDA. 03/08/2026 Valid
Aplicativo iCan Reach
81464750220
II Domo Salute Consultoria Regulatória Ltda 03/08/2026 Valid
mySugr Glucose Insights
10287411797
III ROCHE DIAGNÓSTICA BRASIL LTDA 15/06/2026 Until 15/06/2036
BDXpert™ System
10033430917
II BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA. 08/06/2026 Valid
MATCH IT! Platelet Antibody
80003610626
I WERFEN MEDICAL LTDA 08/06/2026 Valid
Yuwell Anytime
80102513684
III VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA 08/06/2026 Until 08/06/2036
MATCH IT! Antibody
80003610625
I WERFEN MEDICAL LTDA 18/05/2026 Valid
SIBIONICS Data Bank
82533950154
I MR SAUDE LTDA 18/02/2026 Valid
MatchX
80003610624
II WERFEN MEDICAL LTDA 12/01/2026 Valid
PRISCA 5
10345162551
II SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA 01/12/2025 Valid
ASI IVD System BandView
80117581266
II EMERGO BRAZIL IMPORT IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS HOSPITALARES LTDA 01/12/2025 Valid
Software Basis
80391910022
II PH 7 COMÉRCIO E REPRESENTAÇÕES DE PRODUTOS PARA DIAGNÓSTICOS LTDA 21/07/2025 Valid
SIBIONICS Proview
82533950113
I MR SAUDE LTDA 21/07/2025 Valid
IH-Com
80020690443
II BIO-RAD LABORATORIOS BRASIL LTDA 28/04/2025 Valid
EasyPGX Analysis Software
80502070126
III MOBIUS LIFE SCIENCE INDUSTRIA E COMERCIO DE PRODUTOS PARA LABORATORIOS LTDA 04/11/2024 Until 04/11/2034
GAAD
10287411692
III ROCHE DIAGNÓSTICA BRASIL LTDA 28/05/2024 Until 28/05/2034
BRAHMS Fast Screen Pre I Plus
80254180464
III PHADIA DIAGNOSTICOS LTDA 11/03/2024 Until 11/03/2034