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PRESTIGE 24i IgG
EUDAMEDClass IVD General (EU MDR)
Ref 4-331Model PRESTIGE 24i IgG
Identity
- Trade Name
- PRESTIGE 24i IgG EUDAMED
- Device Name
- IgG EUDAMED
- Model / Reference
- PRESTIGE 24i IgG EUDAMED4-331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514643318 EUDAMED
- Basic UDI-DI
- B-05907514643318 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G 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
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
PRESTIGE 24i IgG by PZ CORMAY Spółka Akcyjna — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-05907514643318 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (1)
- EUDAMED 4a82e1c7-0d9d-47bf-aac9-d0e97e5ce40a 61 fields · synced Oct 6, 2026