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Medical device registration with ANVISA

Search by number, product, registration holder or CNPJ. The data comes from ANVISA's open data publications and is updated here daily.

AllClass IClass IIClass IIIClass IVExpired

Registrations held by ORBITAE DIAGNOSTICOS S/Aremove

109 registrations

ProductRegistration holderClassValidity
AMP Assure Test80885650019ORBITAE DIAGNOSTICOS S/AIIValid
Alcohol Assure Test80885650029ORBITAE DIAGNOSTICOS S/AIIValid
Alcohol Assure Test Saliva80885650030ORBITAE DIAGNOSTICOS S/AIIValid
Analisador FIA 5300 Assure80885650098ORBITAE DIAGNOSTICOS S/AIIValid
Analisador Imuchem POC80885650073ORBITAE DIAGNOSTICOS S/AIIValid
Analisador de Ácido Úrico Acuteck80885650095ORBITAE DIAGNOSTICOS S/AIIValid
CK-MB FIA Assure Test80885650101ORBITAE DIAGNOSTICOS S/AIII03/11/2035
COC Assure Test80885650021ORBITAE DIAGNOSTICOS S/AIIValid
COC/THC Assure Test80885650015ORBITAE DIAGNOSTICOS S/AIIValid
COVID-19 Ag Assure Test80885650043ORBITAE DIAGNOSTICOS S/AIII31/05/2031
COVID-19 IgG/IgM Alfa Test80885650025ORBITAE DIAGNOSTICOS S/AIII25/05/2030
COVID-19 IgG/IgM Assure Test80885650045ORBITAE DIAGNOSTICOS S/AIII05/07/2031
Covid-19 Ag Flu A & B Combo Assure Test80885650044ORBITAE DIAGNOSTICOS S/AIII05/07/2031
Covid-19 Ag II Assure Test80885650047ORBITAE DIAGNOSTICOS S/AIII19/07/2031
Covid-19 Ag III Assure Test80885650049ORBITAE DIAGNOSTICOS S/AIII16/08/2031
D-Dímero FIA Assure Test80885650103ORBITAE DIAGNOSTICOS S/AIII17/11/2035
DOA Reader Ultimed80885650011ORBITAE DIAGNOSTICOS S/AIIValid
DSR-Plus IFP Reader80885650039ORBITAE DIAGNOSTICOS S/AIIValid
Dengue NS1 Assure Test80885650072ORBITAE DIAGNOSTICOS S/AIII13/03/2033
DrAccu ß-HCG Assure Test80885650087ORBITAE DIAGNOSTICOS S/AIIValid
ETG Assure Test80885650027ORBITAE DIAGNOSTICOS S/AIIValid
FOB Assure Test80885650062ORBITAE DIAGNOSTICOS S/AIII01/08/2032
FaStep Covid-19 Ag Assure Autoteste80885650064ORBITAE DIAGNOSTICOS S/AIII15/08/2032
FaStep Covid-19 Ag II Assure Autoteste80885650065ORBITAE DIAGNOSTICOS S/AIII22/08/2032
FaStep Covid-19 Ag Saliva Assure Autoteste80885650063ORBITAE DIAGNOSTICOS S/AIII15/08/2032

Source: ANVISA open data, medical device file. The database provides registration validity, rather than registration status: a 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.

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HSC manages medical device registration with ANVISA, from risk classification to monitoring the application.

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