ANVISA registration

hs-cTnI (Troponina Ultrassensível) FIA Assure Test

Registration 80885650107. TROPONINA

Registration details

Registration number80885650107
Application number25351177495202571
Technical nameTROPONINA
Risk classIII
Published on08/12/2025
ValidityValid until 08/12/2035

Registration holder

Legal nameORBITAE DIAGNOSTICOS S/A
CNPJ11.162.384/0001-65

Manufacturer

  • ASSURE TECH. (HANGZHOU) CO., LTD CHINA, REPÚBLICA POPULAR

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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.

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