ANVISA registration
Família hs-cTnI Quantitative Test Kit (Time-Resolved FIA)
Registration 82444370308. TROPONINA
Registration details
| Registration number | 82444370308 |
|---|---|
| Application number | 25351181022202579 |
| Technical name | TROPONINA |
| Risk class | III |
| Published on | 29/12/2025 |
| Validity | Valid until 29/12/2035 |
Registration holder
| Legal name | Enzytec Biotecnologia Ltda. |
|---|---|
| CNPJ | 07.214.566/0001-65 |
Manufacturer
- ZHEJIANG ORIENT GENE BIOTECH CO., LTD. CHINA, REPÚBLICA POPULAR
Other registrations held by Enzytec Biotecnologia Ltda.view all
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