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AURYX 90 NSE Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref I20-R0123Model AURYX 90 NSE Reagent KitRef I20-R0124
Identity
- Trade Name
- AURYX 90 NSE Reagent Kit EUDAMED
- Device Name
- AURYX 90 NSE Reagent Kit EUDAMED
- Model / Reference
- AURYX 90 NSE Reagent Kit EUDAMEDI20-R0123 EUDAMEDI20-R0124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514601097 EUDAMED05907514601103 EUDAMED
- Basic UDI-DI
- B-05907514601097 EUDAMEDB-05907514601103 EUDAMED
- EMDN Code
- W0102039007 NEURON SPECIFIC ENOLASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
AURYX 90 NSE Reagent Kit by PZ CORMAY Spółka Akcyjna — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05907514601097 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (2)
- EUDAMED 5a5984dd-954b-48cc-9145-6f85ccd7f2f8 61 fields · synced Oct 6, 2026
- EUDAMED 6e8579c9-97be-4cca-9a6b-05b8a58ee685 61 fields · synced May 18, 2026