ANVISA registration

CELER WONDFO SARS-CoV-2 Ag AUTO TESTE

Registration 80537410106. AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)

Registration details

Registration number80537410106
Application number25351052657202217
Technical nameAUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
Risk classIII
Published on28/03/2022
ValidityValid until 28/03/2032

Registration holder

Legal nameCELER BIOTECNOLOGIA S/A
CNPJ04.846.613/0001-03

Manufacturer

  • GUANGZHOU WONDFO BIOTECH CO., LTD. CHINA, REPÚBLICA POPULAR

Other registrations held by CELER BIOTECNOLOGIA S/Aview all

SPECTRUM

80537410001

POLARIS

80537410002

AQUARI

80537410003

FINECARE FIA METER

80537410029

Finecare Proteína C Reativa (PCR) Teste Rápido Quantitativo

80537410030

Finecare HbA1c Teste Rápido Quantitativo

80537410031

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