ANVISA registration

Luminis FIA CK-MB

Registration 80474870168. CREATINOQUINASE ISOENZIMAS (CKMB, CKBB, CKMM)

Registration details

Registration number80474870168
Application number25351098583202516
Technical nameCREATINOQUINASE ISOENZIMAS (CKMB, CKBB, CKMM)
Risk classIII
Published on08/09/2025
ValidityValid until 08/09/2035

Registration holder

Legal nameBIOSUL PRODUTOS DIAGNOSTICOS LTDA - ME
CNPJ05.905.525/0001-90

Manufacturer

  • QINGDAO HIGHTOP BIOTECH CO.,LTD. CHINA, REPÚBLICA POPULAR

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