ANVISA registration

CK-MB FIA Assure Test

Registration 80885650101. CREATINOQUINASE ISOENZIMAS (CKMB, CKBB, CKMM)

Registration details

Registration number80885650101
Application number25351147225202536
Technical nameCREATINOQUINASE ISOENZIMAS (CKMB, CKBB, CKMM)
Risk classIII
Published on03/11/2025
ValidityValid until 03/11/2035

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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