AURYX 90 Anti-TPO Reagent Kit
by PZ CORMAY Spółka Akcyjna Poland EUDAMED
Ref I20-R0026Model AURYX 90 Anti-TPO Reagent Kit
EMDN W0102100301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-05907514600403 | Date25 Jul 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- AURYX 90 Anti-TPO Reagent Kit, I20-R0026
- Primary DI / UDI-DI
- 05907514600403
- Basic UDI-DI
- B-05907514600403
- EMDN Code
- W0102100301 Thyroid peroxidase (incl. microsomal) antibodies
- 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 0054c24f-64c9-40ae-9558-afa0261657ad