ORBITAE DIAGNOSTICOS S/A

Brazilian registration holder · CNPJ 11.162.384/0001-65

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

111registrations
109currently valid
9manufacturers
55device types
2014first registration
2class I
70class II
30class III
9class IV

Manufacturers represented

  • · China↗ 69
  • · United States↗ 11
  • · South Korea↗ 9
  • · South Korea↗ 6
  • · United Kingdom↗ 5
  • · China↗ 3
  • · Germany↗ 2
  • · China↗ 2
  • · Germany↗ 2

Device types

  • ↗ 27
  • ↗ 10
  • ↗ 4
  • ↗ 3
  • ↗ 3
  • ↗ 3
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2

Countries of manufacture

  • ↗ 74
  • ↗ 15
  • ↗ 11
  • ↗ 5
  • ↗ 4

New registrations per year

  • 20149
  • 201512
  • 20191
  • 202017
  • 202114
  • 202216
  • 202317
  • 202522
  • 20263

Registrations (page 1 of 3, highest registration number first)

ProductDevice typeClass ManufacturerPublishedStatus
Lanceta Estéril de Segurança Orbitae
80885659002
Lancets II TIANJIN RILIFINE MEDICAL DEVICE CO., LTD. 02/10/2023 Valid
Lanceta Estéril para Lancetador Orbitae
80885659001
Lancets II TIANJIN RILIFINE MEDICAL DEVICE CO., LTD. 02/10/2023 Valid
Tira Teste de Perfil Lipídico Acuteck
80885650111
Self-test for cholesterol and triglycerides II ASSURE TECH. (HANGZHOU) CO., LTD 05/10/2026 Valid
PSA FIA Assure Test
80885650110
Prostate-specific antigen (PSA) III ASSURE TECH. (HANGZHOU) CO., LTD 21/09/2026 Until 21/09/2036
Mioglobina FIA Assure Test
80885650109
Myoglobin III ASSURE TECH. (HANGZHOU) CO., LTD 19/01/2026 Until 19/01/2036
Troponina I FIA Assure Test
80885650108
Troponin III ASSURE TECH. (HANGZHOU) CO., LTD 29/12/2025 Until 29/12/2035
hs-cTnI (Troponina Ultrassensível) FIA Assure Test
80885650107
Troponin III ASSURE TECH. (HANGZHOU) CO., LTD 08/12/2025 Until 08/12/2035
TSH FIA Assure Test
80885650106
Thyroid-stimulating hormone (TSH) II ASSURE TECH. (HANGZHOU) CO., LTD 01/12/2025 Valid
Vitamina D3 FIA Assure Test
80885650105
25-Hydroxyvitamin D3 (vitamin D) II ASSURE TECH. (HANGZHOU) CO., LTD 24/11/2025 Valid
cTnI/Myo/CK-MB FIA Assure Test
80885650104
Combined parameters in one product - class III III ASSURE TECH. (HANGZHOU) CO., LTD 17/11/2025 Until 17/11/2035
D-Dímero FIA Assure Test
80885650103
D-dimer III ASSURE TECH. (HANGZHOU) CO., LTD 17/11/2025 Until 17/11/2035
NT-ProBNP FIA Assure Test
80885650102
Human brain natriuretic peptide (BNP) III ASSURE TECH. (HANGZHOU) CO., LTD 17/11/2025 Until 17/11/2035
CK-MB FIA Assure Test
80885650101
Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) III ASSURE TECH. (HANGZHOU) CO., LTD 03/11/2025 Until 03/11/2035
Trio Viral Assure Test
80885650100
Combined parameters - respiratory panel III ASSURE TECH. (HANGZHOU) CO., LTD 24/10/2025 Until 24/10/2035
Vitamina B12 FIA Assure Test
80885650099
Vitamin B12 II ASSURE TECH. (HANGZHOU) CO., LTD 13/10/2025 Valid
Analisador FIA 5300 Assure
80885650098
Immunoassay instrument II ASSURE TECH. (HANGZHOU) CO., LTD 22/09/2025 Valid
Painel Lipídico Acuteck
80885650097
Total cholesterol II ASSURE TECH. (HANGZHOU) CO., LTD 08/09/2025 Valid
Ácido Úrico Acuteck Strip
80885650096
Uric acid II ASSURE TECH. (HANGZHOU) CO., LTD 01/09/2025 Valid
Analisador de Ácido Úrico Acuteck
80885650095
Uric acid II ASSURE TECH. (HANGZHOU) CO., LTD 01/09/2025 Valid
HbA1c Assure FIA Test
80885650094
Glycated hemoglobin (HbA1c) II ASSURE TECH. (HANGZHOU) CO., LTD 01/09/2025 Valid
FaStep HIV Ab Saliva Assure Autoteste
80885650093
Self-test for human immunodeficiency virus (HIV) antibodies IV ASSURE TECH. (HANGZHOU) CO., LTD 25/08/2025 Until 25/08/2035
Tira Teste de Glicemia Acuteck
80885650091
Glucose - point-of-care testing (professional) II ASSURE TECH. (HANGZHOU) CO., LTD 11/08/2025 Valid
Tira teste de Painel Lipídico Assure Test
80885650090
Combined parameters in one product - class II II ASSURE TECH. (HANGZHOU) CO., LTD 11/08/2025 Valid
HIV/Sífilis Combo Assure Test
80885650089
HIV-1/HIV-2 and Treponema pallidum antibodies IV ASSURE TECH. (HANGZHOU) CO., LTD 05/05/2025 Until 05/05/2035
Monitor de Glicemia Acuteck
80885650088
Glucose instrument - point-of-care testing (professional) II ASSURE TECH. (HANGZHOU) CO., LTD 05/05/2025 Valid
DrAccu ß-HCG Assure Test
80885650087
Beta human chorionic gonadotropin (beta-hCG) II ASSURE TECH. (HANGZHOU) CO., LTD 27/01/2025 Valid
HCV Assure Test
80885650086
Total antibody to hepatitis C virus (anti-HCV) IV ASSURE TECH. (HANGZHOU) CO., LTD 13/01/2025 Until 13/01/2035
Perfil Lipídico Sejoy
80885650084
Total cholesterol II SEJOY BIOMEDICAL CO., LTD. 16/10/2023 Valid
Monitor de Perfil Lipídico Sejoy
80885650083
Analyzer for general chemistry, hormones, drugs or proteins II SEJOY BIOMEDICAL CO., LTD. 16/10/2023 Valid
Lancetador Orbitae
80885650082
Lancing device I TIANJIN RILIFINE MEDICAL DEVICE CO., LTD. 09/10/2023 Valid
Imuchem CT POC
80885650081
Total cholesterol II TASCOM CO., LTD 29/05/2023 Valid
Imuchem AST POC
80885650080
Aspartate aminotransferase (AST/GOT) II TASCOM CO., LTD 29/05/2023 Valid
Imuchem CRE POC
80885650079
Creatinine II TASCOM CO., LTD 29/05/2023 Valid
Imuchem CK POC
80885650078
Creatine kinase (CK) II TASCOM CO., LTD 29/05/2023 Valid
Imuchem TG POC
80885650077
Triglycerides II TASCOM CO., LTD 29/05/2023 Valid
Imuchem ALT POC
80885650076
Alanine aminotransferase (ALT/GPT) II TASCOM CO., LTD 29/05/2023 Valid
Imuchem BUN POC
80885650075
Urea II TASCOM CO., LTD 29/05/2023 Valid
Imuchem PCR POC
80885650074
C-reactive protein (CRP) II TASCOM CO., LTD 29/05/2023 Valid
Analisador Imuchem POC
80885650073
Immunoassay instrument II TASCOM CO., LTD 29/05/2023 Valid
Dengue NS1 Assure Test
80885650072
Dengue III ASSURE TECH. (HANGZHOU) CO., LTD 13/03/2023 Until 13/03/2033
HIV 1 + O / 2 Assure Test
80885650071
HIV-1/HIV-2 antibody IV ASSURE TECH. (HANGZHOU) CO., LTD 16/01/2023 Until 16/01/2033
Sífilis Assure Test
80885650070
Treponema pallidum IgG/IgM IV ASSURE TECH. (HANGZHOU) CO., LTD 09/01/2023 Until 09/01/2033
HBsAg Assure Test
80885650069
Hepatitis B surface antigen (HBsAg) IV ASSURE TECH. (HANGZHOU) CO., LTD 03/10/2022 Until 03/10/2032
Multi 6 Assure Test
80885650068
Drugs of abuse panel II ASSURE TECH. (HANGZHOU) CO., LTD 29/09/2022 Valid
Gonorréia Assure Test
80885650067
Neisseria gonorrhoeae antigen IV ASSURE TECH. (HANGZHOU) CO., LTD. 22/08/2022 Until 22/08/2032
Zika IgG/IgM Assure Test
80885650066
Zika virus IgM/IgG IV ASSURE TECH. (HANGZHOU) CO., LTD 22/08/2022 Until 22/08/2032
FaStep Covid-19 Ag II Assure Autoteste
80885650065
Self-test for SARS-CoV-2 (coronavirus) antigen III ASSURE TECH. (HANGZHOU) CO., LTD. 22/08/2022 Until 22/08/2032
FaStep Covid-19 Ag Assure Autoteste
80885650064
Self-test for SARS-CoV-2 (coronavirus) antigen III ASSURE TECH. (HANGZHOU) CO., LTD. 15/08/2022 Until 15/08/2032
FaStep Covid-19 Ag Saliva Assure Autoteste
80885650063
Self-test for SARS-CoV-2 (coronavirus) antigen III ASSURE TECH. (HANGZHOU) CO., LTD. 15/08/2022 Until 15/08/2032
FOB Assure Test
80885650062
Fecal occult blood III ASSURE TECH. (HANGZHOU) CO., LTD. 01/08/2022 Until 01/08/2032