ANVISA registration

GeneFinder STD II (MG/MH/TV) Multiplex Real-time PCR kit

Registration 81914040027. PARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III

Registration details

Registration number81914040027
Application number25351385136202243
Technical namePARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III
Risk classIII
Published on02/05/2023
ValidityValid until 02/05/2033

Registration holder

Legal nameUNA MEDIC IMPORTAÇAO E EXPORTAÇAO LTDA
CNPJ32.247.380/0001-50

Manufacturer

  • OSANG HEALTHCARE CO., LTD. CORÉIA DO SUL

Other registrations held by UNA MEDIC IMPORTAÇAO E EXPORTAÇAO LTDAview all

GeneFinder COVID-19 Plus RealAmp Kit

81914040002

alphaPrep KIT DE EXTRAÇÃO DE DNA/RNA VIRAL

81914040003

EXTRATOR DE ÁCIDO NUCLEICO

81914040004

GeneFinder COVID-19 Fast RealAmp Kit

81914040006

GeneFinder COVID-19 Flu A&B RealAmp Kit

81914040007

GeneFinder COVID-19 Ag Plus

81914040008

Source: ANVISA

Source: ANVISA open data, medical device file, updated daily. The public database provides registration validity, rather than registration status: this 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.

Next step

Medical device registration with ANVISA

HSC manages the process from risk classification to liaising with the regulator, in Brazil and more than 40 other countries.

Speak to a specialist