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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
ETG Assure Test80885650027ORBITAE DIAGNOSTICOS S/AIIValid
Multi 4 Assure Test80885650028ORBITAE DIAGNOSTICOS S/AIIValid
Alcohol Assure Test80885650029ORBITAE DIAGNOSTICOS S/AIIValid
Alcohol Assure Test Saliva80885650030ORBITAE DIAGNOSTICOS S/AIIValid
Multi 7 Assure Test + Alcohol80885650031ORBITAE DIAGNOSTICOS S/AIIValid
Multi 6 Saliva Assure Test80885650032ORBITAE DIAGNOSTICOS S/AIIValid
Instant View Plus Covid-19 Ag View Alfa Test80885650033ORBITAE DIAGNOSTICOS S/AIII10/08/2030
Securetec WipeAlyser Reader80885650034ORBITAE DIAGNOSTICOS S/AIIValid
Securetec DrugWipe 5 S Test80885650035ORBITAE DIAGNOSTICOS S/AIIValid
Multi 13 Assure Test + Alcohol80885650036ORBITAE DIAGNOSTICOS S/AIIValid
THC/COC/OPI/AMP IFP Test80885650037ORBITAE DIAGNOSTICOS S/AIIValid
OPI/MAMP/COC/THC IFP Test80885650038ORBITAE DIAGNOSTICOS S/AIIValid
DSR-Plus IFP Reader80885650039ORBITAE DIAGNOSTICOS S/AIIValid
GENEDIA W COVID-19 Ag80885650040ORBITAE DIAGNOSTICOS S/AIII18/01/2031
GENEDIA W COVID-19 Real-Time RT-PCR80885650041ORBITAE DIAGNOSTICOS S/AIII01/03/2031
GENEDIA W ONE COVID-19 IgM/IgG80885650042ORBITAE DIAGNOSTICOS S/AIII08/03/2031
COVID-19 Ag Assure Test80885650043ORBITAE DIAGNOSTICOS S/AIII31/05/2031
Covid-19 Ag Flu A & B Combo Assure Test80885650044ORBITAE DIAGNOSTICOS S/AIII05/07/2031
COVID-19 IgG/IgM Assure Test80885650045ORBITAE DIAGNOSTICOS S/AIII05/07/2031
GENEDIA Multi Influenza Ag80885650046ORBITAE DIAGNOSTICOS S/AIII19/07/2031
Covid-19 Ag II Assure Test80885650047ORBITAE DIAGNOSTICOS S/AIII19/07/2031
Multi 12 Urina Assure Test80885650048ORBITAE DIAGNOSTICOS S/AIIValid
Covid-19 Ag III Assure Test80885650049ORBITAE DIAGNOSTICOS S/AIII16/08/2031
GENEDIA Influenza A/B Ag II80885650050ORBITAE DIAGNOSTICOS S/AIII30/08/2031
Multi 6 Urina Assure Test80885650052ORBITAE DIAGNOSTICOS S/AIIValid

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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