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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
FaStep HIV Ab Saliva Assure Autoteste80885650093ORBITAE DIAGNOSTICOS S/AIV25/08/2035
GENEDIA Influenza A/B Ag II80885650050ORBITAE DIAGNOSTICOS S/AIII30/08/2031
GENEDIA Multi Influenza Ag80885650046ORBITAE DIAGNOSTICOS S/AIII19/07/2031
GENEDIA W COVID-19 Ag80885650040ORBITAE DIAGNOSTICOS S/AIII18/01/2031
GENEDIA W COVID-19 Ag II80885650053ORBITAE DIAGNOSTICOS S/AIII18/10/2031
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
Gonorréia Assure Test80885650067ORBITAE DIAGNOSTICOS S/AIV22/08/2032
H. pylori AC Assure Test80885650055ORBITAE DIAGNOSTICOS S/AIIValid
H. pylori Ag Assure Test80885650057ORBITAE DIAGNOSTICOS S/AIIValid
HBsAg Assure Test80885650069ORBITAE DIAGNOSTICOS S/AIV03/10/2032
HCV Assure Test80885650086ORBITAE DIAGNOSTICOS S/AIV13/01/2035
HIV 1 + O / 2 Assure Test80885650071ORBITAE DIAGNOSTICOS S/AIV16/01/2033
HIV/Sífilis Combo Assure Test80885650089ORBITAE DIAGNOSTICOS S/AIV05/05/2035
HbA1c Assure FIA Test80885650094ORBITAE DIAGNOSTICOS S/AIIValid
IFP Reader 100080885650023ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem ALT POC80885650076ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem AST POC80885650080ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem BUN POC80885650075ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem CK POC80885650078ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem CRE POC80885650079ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem CT POC80885650081ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem PCR POC80885650074ORBITAE DIAGNOSTICOS S/AIIValid
Imuchem TG POC80885650077ORBITAE DIAGNOSTICOS S/AIIValid
Influenza A/B Assure Test80885650060ORBITAE DIAGNOSTICOS S/AIII01/08/2032

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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