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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
GENEDIA W COVID-19 Ag II80885650053ORBITAE DIAGNOSTICOS S/AIII18/10/2031
RSV Assure Test80885650054ORBITAE DIAGNOSTICOS S/AIIValid
H. pylori AC Assure Test80885650055ORBITAE DIAGNOSTICOS S/AIIValid
Norovírus Assure Test80885650056ORBITAE DIAGNOSTICOS S/AIIValid
H. pylori Ag Assure Test80885650057ORBITAE DIAGNOSTICOS S/AIIValid
Rotavírus-Adenovírus Assure Test80885650058ORBITAE DIAGNOSTICOS S/AIIValid
Malária P.f/Pan Assure Test80885650059ORBITAE DIAGNOSTICOS S/AIV01/08/2032
Influenza A/B Assure Test80885650060ORBITAE DIAGNOSTICOS S/AIII01/08/2032
Strep A Assure Test80885650061ORBITAE DIAGNOSTICOS S/AIII01/08/2032
FOB Assure Test80885650062ORBITAE DIAGNOSTICOS S/AIII01/08/2032
FaStep Covid-19 Ag Saliva Assure Autoteste80885650063ORBITAE DIAGNOSTICOS S/AIII15/08/2032
FaStep Covid-19 Ag Assure Autoteste80885650064ORBITAE DIAGNOSTICOS S/AIII15/08/2032
FaStep Covid-19 Ag II Assure Autoteste80885650065ORBITAE DIAGNOSTICOS S/AIII22/08/2032
Zika IgG/IgM Assure Test80885650066ORBITAE DIAGNOSTICOS S/AIV22/08/2032
Gonorréia Assure Test80885650067ORBITAE DIAGNOSTICOS S/AIV22/08/2032
Multi 6 Assure Test80885650068ORBITAE DIAGNOSTICOS S/AIIValid
HBsAg Assure Test80885650069ORBITAE DIAGNOSTICOS S/AIV03/10/2032
Sífilis Assure Test80885650070ORBITAE DIAGNOSTICOS S/AIV09/01/2033
HIV 1 + O / 2 Assure Test80885650071ORBITAE DIAGNOSTICOS S/AIV16/01/2033
Dengue NS1 Assure Test80885650072ORBITAE DIAGNOSTICOS S/AIII13/03/2033
Analisador Imuchem POC80885650073ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem PCR POC80885650074ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem BUN POC80885650075ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem ALT POC80885650076ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem TG POC80885650077ORBITAE 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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