ASSURE TECH. (HANGZHOU) CO., LTD

Manufacturer · China

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99registrations in Brazil
99currently valid
6registration holders
51device types
2015first registration

Brazilian registration holders

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  • · latest 2024↗ 12
  • · latest 2018↗ 11
  • · latest 2026↗ 3
  • · latest 2021↗ 3
  • · latest 2023↗ 1

Device types

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Registrations (page 1 of 2, newest first)

ProductDevice typeClass HolderPublishedStatus
Tira Teste de Perfil Lipídico Acuteck
80885650111
Self-test for cholesterol and triglycerides II ORBITAE DIAGNOSTICOS S/A 05/10/2026 Valid
PSA FIA Assure Test
80885650110
Prostate-specific antigen (PSA) III ORBITAE DIAGNOSTICOS S/A 21/09/2026 Until 21/09/2036
Família Teste de Gravidez
80113770064
Self-test for human chorionic gonadotropin (hCG) II ALEXDAN IMPORTAÇÃO E EXPORTAÇÃO LTDA – EPP 23/02/2026 Valid
Família Teste de Menopausa
80113770063
Self-test for follicle-stimulating hormone (FSH) II ALEXDAN IMPORTAÇÃO E EXPORTAÇÃO LTDA – EPP 19/01/2026 Valid
Mioglobina FIA Assure Test
80885650109
Myoglobin III ORBITAE DIAGNOSTICOS S/A 19/01/2026 Until 19/01/2036
Família Autoteste de Gravidez Digital com Indicador de Semanas
80113770060
Self-test for human chorionic gonadotropin (hCG) II ALEXDAN IMPORTAÇÃO E EXPORTAÇÃO LTDA – EPP 05/01/2026 Valid
Troponina I FIA Assure Test
80885650108
Troponin III ORBITAE DIAGNOSTICOS S/A 29/12/2025 Until 29/12/2035
hs-cTnI (Troponina Ultrassensível) FIA Assure Test
80885650107
Troponin III ORBITAE DIAGNOSTICOS S/A 08/12/2025 Until 08/12/2035
TSH FIA Assure Test
80885650106
Thyroid-stimulating hormone (TSH) II ORBITAE DIAGNOSTICOS S/A 01/12/2025 Valid
Vitamina D3 FIA Assure Test
80885650105
25-Hydroxyvitamin D3 (vitamin D) II ORBITAE DIAGNOSTICOS S/A 24/11/2025 Valid
NT-ProBNP FIA Assure Test
80885650102
Human brain natriuretic peptide (BNP) III ORBITAE DIAGNOSTICOS S/A 17/11/2025 Until 17/11/2035
D-Dímero FIA Assure Test
80885650103
D-dimer III ORBITAE DIAGNOSTICOS S/A 17/11/2025 Until 17/11/2035
cTnI/Myo/CK-MB FIA Assure Test
80885650104
Combined parameters in one product - class III III ORBITAE DIAGNOSTICOS S/A 17/11/2025 Until 17/11/2035
CK-MB FIA Assure Test
80885650101
Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) III ORBITAE DIAGNOSTICOS S/A 03/11/2025 Until 03/11/2035
Trio Viral Assure Test
80885650100
Combined parameters - respiratory panel III ORBITAE DIAGNOSTICOS S/A 24/10/2025 Until 24/10/2035
Vitamina B12 FIA Assure Test
80885650099
Vitamin B12 II ORBITAE DIAGNOSTICOS S/A 13/10/2025 Valid
Analisador FIA 5300 Assure
80885650098
Immunoassay instrument II ORBITAE DIAGNOSTICOS S/A 22/09/2025 Valid
Painel Lipídico Acuteck
80885650097
Total cholesterol II ORBITAE DIAGNOSTICOS S/A 08/09/2025 Valid
HbA1c Assure FIA Test
80885650094
Glycated hemoglobin (HbA1c) II ORBITAE DIAGNOSTICOS S/A 01/09/2025 Valid
Analisador de Ácido Úrico Acuteck
80885650095
Uric acid II ORBITAE DIAGNOSTICOS S/A 01/09/2025 Valid
Ácido Úrico Acuteck Strip
80885650096
Uric acid II ORBITAE DIAGNOSTICOS S/A 01/09/2025 Valid
FaStep HIV Ab Saliva Assure Autoteste
80885650093
Self-test for human immunodeficiency virus (HIV) antibodies IV ORBITAE DIAGNOSTICOS S/A 25/08/2025 Until 25/08/2035
Tira teste de Painel Lipídico Assure Test
80885650090
Combined parameters in one product - class II II ORBITAE DIAGNOSTICOS S/A 11/08/2025 Valid
Tira Teste de Glicemia Acuteck
80885650091
Glucose - point-of-care testing (professional) II ORBITAE DIAGNOSTICOS S/A 11/08/2025 Valid
Monitor de Glicemia Acuteck
80885650088
Glucose instrument - point-of-care testing (professional) II ORBITAE DIAGNOSTICOS S/A 05/05/2025 Valid
HIV/Sífilis Combo Assure Test
80885650089
HIV-1/HIV-2 and Treponema pallidum antibodies IV ORBITAE DIAGNOSTICOS S/A 05/05/2025 Until 05/05/2035
DrAccu ß-HCG Assure Test
80885650087
Beta human chorionic gonadotropin (beta-hCG) II ORBITAE DIAGNOSTICOS S/A 27/01/2025 Valid
HCV Assure Test
80885650086
Total antibody to hepatitis C virus (anti-HCV) IV ORBITAE DIAGNOSTICOS S/A 13/01/2025 Until 13/01/2035
Zolpidem ZOL Rápido
80277090071
Zolpidem II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 09/09/2024 Valid
Dia Sure ETG
80277090069
Ethyl glucuronide (EtG) II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 08/07/2024 Valid
Dia Sure ALC
80277090070
Alcohol II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 08/07/2024 Valid
DIA SURE (MIDSTREAM) – AMP/BZO/COC/METH/OPI/THC
80277090067
Drugs of abuse panel II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 13/11/2023 Valid
DIA SURE (CUP) – AMP/BZO/COC/MDMA/MET/OPI/OXY/THC
80277090068
Drugs of abuse panel II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 13/11/2023 Valid
Fast Test Gravidez Semanas Digital
82533950032
Self-test for human chorionic gonadotropin (hCG) II MR SAUDE LTDA 11/09/2023 Valid
Dia Sure K2
80277090062
Cannabinoids II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 10/07/2023 Valid
Dia Sure Multi Drogas 5
80277090063
Drugs of abuse panel II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 10/07/2023 Valid
Dia Sure Multi Drogas 12
80277090064
Drugs of abuse panel II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 10/07/2023 Valid
Dia Sure Multi Drogas 10
80277090065
Drugs of abuse panel II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 10/07/2023 Valid
Dia Sure Multi Drogas 2
80277090066
Drugs of abuse panel II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 10/07/2023 Valid
Dia Sure THC
80277090057
Drugs of abuse panel II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 02/05/2023 Valid
Dia Sure COC
80277090059
Drugs of abuse panel II GRIMEXTUR- IMPORTAÇÃO E EXPORTAÇÃO DO BRASIL LTDA ME 02/05/2023 Valid
Dengue NS1 Assure Test
80885650072
Dengue III ORBITAE DIAGNOSTICOS S/A 13/03/2023 Until 13/03/2033
HIV 1 + O / 2 Assure Test
80885650071
HIV-1/HIV-2 antibody IV ORBITAE DIAGNOSTICOS S/A 16/01/2023 Until 16/01/2033
Sífilis Assure Test
80885650070
Treponema pallidum IgG/IgM IV ORBITAE DIAGNOSTICOS S/A 09/01/2023 Until 09/01/2033
HBsAg Assure Test
80885650069
Hepatitis B surface antigen (HBsAg) IV ORBITAE DIAGNOSTICOS S/A 03/10/2022 Until 03/10/2032
Multi 6 Assure Test
80885650068
Drugs of abuse panel II ORBITAE DIAGNOSTICOS S/A 29/09/2022 Valid
FaStep Covid-19 Ag II Assure Autoteste
80885650065
Self-test for SARS-CoV-2 (coronavirus) antigen III ORBITAE DIAGNOSTICOS S/A 22/08/2022 Until 22/08/2032
Zika IgG/IgM Assure Test
80885650066
Zika virus IgM/IgG IV ORBITAE DIAGNOSTICOS S/A 22/08/2022 Until 22/08/2032
Gonorréia Assure Test
80885650067
Neisseria gonorrhoeae antigen IV ORBITAE DIAGNOSTICOS S/A 22/08/2022 Until 22/08/2032
FaStep Covid-19 Ag Saliva Assure Autoteste
80885650063
Self-test for SARS-CoV-2 (coronavirus) antigen III ORBITAE DIAGNOSTICOS S/A 15/08/2022 Until 15/08/2032