FUNDACAO OSWALDO CRUZ

Brazilian registration holder · CNPJ 33.781.055/0001-35

Tick manufacturers, device types or countries below to filter this page.

80registrations
46currently valid
5manufacturers
24device types
1999first registration
4class I
4class II
37class III
23class IV
12old classification

Manufacturers represented

  • · Brazil↗ 33
  • · Brazil↗ 10
  • · United States↗ 1
  • · China↗ 1
  • · Brazil↗ 1

Device types

  • ↗ 6
  • ↗ 4
  • ↗ 4
  • ↗ 3
  • ↗ 3
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 1
  • ↗ 1
  • ↗ 1

Countries of manufacture

New registrations per year

  • 19998
  • 20004
  • 20012
  • 20022
  • 20043
  • 20062
  • 20081
  • 20103
  • 20112
  • 20131
  • 20142
  • 20162
  • 20171
  • 20181
  • 20193
  • 20208
  • 20216
  • 202212
  • 20233
  • 20244
  • 20256
  • 20264

Registrations (page 1 of 2, highest registration number first)

ProductDevice typeClass ManufacturerPublishedStatus
Caneta para Insulina Bio-Manguinhos
80142179001
Needle-free medication/vaccine injector, mechanical II GANGAN MEDICAL TECHNOLOGY JIANGSU CO., LTD 09/03/2026 Valid
Kit Febre Amarela One Bio- Manguinhos
80142170079
Yellow fever III INSTITUTO DE BIOLOGIA MOLECULAR DO PARANÁ 08/09/2026 Until 08/09/2036
TR COVID-19 AG RV – BIO-MANGUINHOS
80142170078
Coronavirus III FUNDAÇÃO OSWALDO CRUZ 08/09/2026 Until 08/09/2036
TR Leptospirose IgG/IgM Bio-Manguinhos
80142170077
Leptospira spp. III Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 23/03/2026 Until 23/03/2036
TR HIV 1/2 - BIO-MANGUINHOS
80142170076
HIV-1/HIV-2 antibody IV Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 28/07/2025 Until 28/07/2035
TR Hantavírus IgM Bio-Manguinhos
80142170075
Hantavirus III Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 07/04/2025 Until 07/04/2035
TR DENGUE IgG/IgM Bio-Manguinhos
80142170074
Dengue III Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 24/03/2025 Until 24/03/2035
TR DENGUE NS1 Ag BIO-MANGUINHOS
80142170073
Dengue III Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 24/03/2025 Until 24/03/2035
KIT MOLECULAR MAYV/ OROV BIO-MANGUINHOS
80142170072
Mayaro and Oropouche III Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 05/03/2025 Until 05/03/2035
KIT MOLECULAR PAINEL DE VÍRUS RESPIRATÓRIO (VR 1/VR 2) BIO-MANGUINHOS
80142170071
Combined parameters - respiratory panel III Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 27/01/2025 Until 27/01/2035
TR LVH - Bio-Manguinhos
80142170070
Leishmania spp. III Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 11/11/2024 Until 11/11/2034
TR Malária Pf/Pan Ag - Bio-Manguinhos
80142170069
Plasmodium antigen (multiple species) IV FUNDAÇÃO OSWALDO CRUZ 02/09/2024 Until 02/09/2034
TR HIV/SIFILIS COMBO - Bio-Manguinhos
80142170068
HIV-1/HIV-2 and Treponema pallidum antibodies IV FUNDAÇÃO OSWALDO CRUZ 17/06/2024 Until 17/06/2034
TR Sífilis – Bio-Manguinhos
80142170067
Treponema pallidum total antibodies IV FUNDAÇÃO OSWALDO CRUZ 13/05/2024 Until 13/05/2034
TR Malária Pf/Pv Ag - Bio-Manguinhos
80142170066
Plasmodium antigen (multiple species) IV FUNDAÇÃO OSWALDO CRUZ 04/12/2023 Until 04/12/2033
Kit Molecular VS/VR Bio-Manguinhos
80142170065
Combined parameters in one product - class III III Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos - 04/09/2023 Until 04/09/2033
TR SARS-COV-2 IGG - BIO-MANGUINHOS
80142170064
Not yet published III Not yet published 27/02/2023 Cancelled 25/08/2025
KIT MOLECULAR MONKEYPOX (MPXV) BIO-MANGUINHOS
80142170063
Orthopoxvirus III FUNDAÇÃO OSWALDO CRUZ 26/09/2022 Until 26/09/2032
KIT MOLECULAR MULTIPLEX OPXV/ MPXV/ VZV/ RP Bio-Manguinhos
80142170062
Orthopoxvirus III FUNDAÇÃO OSWALDO CRUZ 20/09/2022 Until 20/09/2032
KIT MOLECULAR ZC D-TIPAGEM – Bio-Manguinhos
80142170061
Chikungunya, dengue and Zika IV FUNDAÇÃO OSWALDO CRUZ 27/06/2022 Until 27/06/2032
KIT MOLECULAR INFA/INFB/SC2 - Bio-Manguinhos
80142170060
Combined parameters - respiratory panel III FUNDAÇÃO OSWALDO CRUZ 25/04/2022 Until 25/04/2032
Kit Febre Amarela Discriminatório - Bio-Manguinhos
80142170059
Yellow fever III FUNDAÇÃO OSWALDO CRUZ 04/04/2022 Until 04/04/2032
DILUENTE AMOSTRA DOADOR FALECIDO BIO-MANGUINHOS
80142170058
Buffers, diluents and other solutions for laboratory analysis I FUNDAÇÃO OSWALDO CRUZ 25/03/2022 Valid
Kit Molecular 4Plex SC2/VOC Bio-Manguinhos
80142170057
Coronavirus III FUNDAÇÃO OSWALDO CRUZ 21/03/2022 Until 21/03/2032
Kit NAT PLUS HIV/HBV/HCV/Malária Bio-Manguinhos
80142170056
HIV, HBV and HCV nucleic acid IV FUNDAÇÃO OSWALDO CRUZ 21/03/2022 Until 21/03/2032
TR COVID/INF A + B - BIO-MANGUINHOS
80142170055
Combined parameters - respiratory panel III FUNDAÇÃO OSWALDO CRUZ 21/03/2022 Until 21/03/2032
AUTOTESTE HIV 1/2 - BIO-MANGUINHOS
80142170054
Self-test for human immunodeficiency virus (HIV) antibodies IV FUNDAÇÃO OSWALDO CRUZ 21/03/2022 Until 21/03/2032
TR Triplo - Bio-Manguinhos
80142170053
Combined parameters in one product - class III III FUNDAÇÃO OSWALDO CRUZ 07/02/2022 Until 07/02/2032
KIT MOLECULAR SC2 (E/N)
80142170052
Not yet published III Not yet published 31/01/2022 Cancelled 25/08/2025
LUMINÔMETRO - Bio-Manguinhos
80142170051
Not yet published II Not yet published 25/11/2021 Cancelled 07/02/2022
Kit EIE COVID-19 IgG Bio-Manguinhos
80142170050
Coronavirus III FUNDAÇÃO OSWALDO CRUZ 04/10/2021 Until 04/10/2031
TR SARS-CoV-2 Ag - Bio- Manguinhos
80142170049
Coronavirus III FUNDAÇÃO OSWALDO CRUZ 14/06/2021 Until 14/06/2031
TR COVID-19 Ag Bio- Manguinhos
80142170048
Coronavirus III FUNDAÇÃO OSWALDO CRUZ 26/04/2021 Until 26/04/2031
TR DPP® COVID-19 AG Bio-Manguinhos
80142170047
Coronavirus III FUNDAÇÃO OSWALDO CRUZ 29/03/2021 Until 29/03/2031
Kit Febre Amarela - Bio-Manguinhos
80142170046
Yellow fever III FUNDAÇÃO OSWALDO CRUZ 01/02/2021 Until 01/02/2031
Kit Molecular SARS-CoV-2 (EDx) - Bio-Manguinhos
80142170045
Not yet published III Not yet published 03/11/2020 Cancelled 25/08/2025
TR COVID-19 IGM/IGG - Bio-Manguinhos
80142170044
Not yet published III Not yet published 02/07/2020 Cancelled 15/09/2025
TR Chagas Bio-Manguinhos
80142170043
Trypanosoma cruzi total antibodies IV FUNDAÇÃO OSWALDO CRUZ 06/07/2020 Until 06/07/2030
TR DPP® DENGUE NS1 - Bio-Manguinhos
80142170042
Dengue III FUNDAÇÃO OSWALDO CRUZ 22/06/2020 Until 22/06/2030
Kit Molecular SARS-CoV-2 (E/RP) - Bio-Manguinhos
80142170041
Not yet published III Not yet published 14/05/2020 Cancelled 25/08/2025
Kit MOLECULAR SARS-CoV2 (E/P1) - Bio-Manguinhos
80142170040
Not yet published III Not yet published 06/04/2020 Cancelled 31/08/2020
TR DPP® COVID-19 IGM/IGG - Bio-Manguinhos
80142170039
Not yet published III Not yet published 03/04/2020 Cancelled 23/06/2025
CURATIVO ADESIVO
80142170038
Not yet published I Not yet published 30/03/2020 Cancelled 11/05/2020
Kit NAT PLUS HIV/HCV/HBV/MALÁRIA Bio-Manguinhos
80142170037
Not yet published IV Not yet published 09/12/2019 Cancelled 01/12/2020
TR DPP DENGUE IGM/IGG - BIO-MANGUINHOS
80142170036
Dengue III FUNDAÇÃO OSWALDO CRUZ 06/05/2019 Until 06/05/2029
TR DPP® ZDC IGM/IGG - Bio-Manguinhos
80142170035
Chikungunya, dengue and Zika IV FUNDAÇÃO OSWALDO CRUZ 08/04/2019 Until 08/04/2029
TR DPP® CHIKUNGUNYA IGM/IGG - Bio-Manguinhos
80142170034
Chikungunya III FUNDAÇÃO OSWALDO CRUZ 06/08/2018 Until 06/08/2028
Micro Leitor DPP- Bio Manguinhos
80142170033
Chromatography analyzer II CHEMBIO DIAGNOSTIC SYSTEMS, INC. 03/07/2017 Valid
Kit Molecular ZDC – Bio-Manguinhos
80142170032
Not yet published IV Not yet published 19/12/2016 Cancelled 23/06/2025
TR DPP® ZIKA IGM/IGG - Bio-Manguinhos
80142170031
Zika virus IgM/IgG IV FUNDAÇÃO OSWALDO CRUZ 31/10/2016 Until 31/10/2036