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AURYX 90 LH Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref I20-R0094Model AURYX 90 LH Reagent KitRef I20-R0093
Identity
- Trade Name
- AURYX 90 LH Reagent Kit EUDAMED
- Device Name
- AURYX 90 LH Reagent Kit EUDAMED
- Model / Reference
- AURYX 90 LH Reagent Kit EUDAMEDI20-R0094 EUDAMEDI20-R0093 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514600984 EUDAMED05907514600977 EUDAMED
- Basic UDI-DI
- B-05907514600984 EUDAMEDB-05907514600977 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE 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 LH 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-05907514600984 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (2)
- EUDAMED 66336a98-49d2-4d5f-bded-425fddca270a 61 fields · synced Jul 13, 2026
- EUDAMED 5bfb284b-0fad-440c-a18c-b61ceea8de90 61 fields · synced May 17, 2026