AURYX 90 H-FABP Reagent Kit
by PZ CORMAY Spółka Akcyjna Poland EUDAMED
Ref I20-R0035Model AURYX 90 H-FABP Reagent Kit EMDN W01021302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05907514600878 | Date25 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- AURYX 90 H-FABP Reagent Kit, I20-R0035
- Primary DI / UDI-DI
- 05907514600878
- Basic UDI-DI
- B-05907514600878
- EMDN Code
- W01021302 Heart-type fatty acid binding protein
- Device Class
- Class IVD General
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000023053
Other devices from PZ CORMAY Spółka Akcyjna
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 122cd7cb-ccd1-4fa8-962c-0f1d023a9de2