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AURYX 90 cTnI Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref I20-R0027Model AURYX 90 cTnI Reagent KitRef I20-R0028
Identity
- Trade Name
- AURYX 90 cTnI Reagent Kit EUDAMED
- Device Name
- AURYX 90 cTnI Reagent Kit EUDAMED
- Model / Reference
- AURYX 90 cTnI Reagent Kit EUDAMEDI20-R0027 EUDAMEDI20-R0028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514600632 EUDAMED05907514600649 EUDAMED
- Basic UDI-DI
- B-05907514600632 EUDAMEDB-05907514600649 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T 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 cTnI 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-05907514600632 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (2)
- EUDAMED c8364c69-9c7a-46aa-a7b6-31518af5fb74 61 fields · synced Jul 14, 2026
- EUDAMED 6ff8c408-f02f-4dc8-b70c-edf0b8940e52 61 fields · synced May 19, 2026