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PRESTIGE 24i TOTAL IgE
EUDAMEDClass IVD General (EU MDR)
Ref 4-484Model PRESTIGE 24i TOTAL IgERef 4-265Ref 6-304Model CORMAY TOTAL IgE
Identity
- Trade Name
- PRESTIGE 24i TOTAL IgE EUDAMEDCORMAY TOTAL IgE EUDAMED
- Device Name
- TOTAL IgE EUDAMED
- Model / Reference
- PRESTIGE 24i TOTAL IgE EUDAMED4-484 EUDAMED4-265 EUDAMEDCORMAY TOTAL IgE EUDAMED6-304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514644841 EUDAMED05907514642656 EUDAMED05907514663040 EUDAMED
- Basic UDI-DI
- B-05907514644841 EUDAMEDB-05907514642656 EUDAMEDB-05907514663040 EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL 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
PRESTIGE 24i TOTAL IgE 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-05907514644841 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (3)
- EUDAMED 66a3e8fd-5840-41a4-b339-04ff25b0e184 61 fields · synced Oct 6, 2026
- EUDAMED 3138f64b-383e-404a-8ade-dc3e2239530d 61 fields · synced May 17, 2026
- EUDAMED c59709a6-3ad9-4eb1-8dcd-29b2f5913153 61 fields · synced May 18, 2026