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PRESTIGE 24i HbA1c DIRECT
EUDAMEDClass IVD General (EU MDR)
Ref 4-300Model PRESTIGE 24i HbA1c DIRECTRef 4-301
Identity
- Trade Name
- PRESTIGE 24i HbA1c DIRECT EUDAMED
- Device Name
- HbA1c DIRECT EUDAMED
- Model / Reference
- PRESTIGE 24i HbA1c DIRECT EUDAMED4-300 EUDAMED4-301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514643004 EUDAMED05907514643011 EUDAMED
- Basic UDI-DI
- B-05907514643004 EUDAMEDB-05907514643011 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) 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 HbA1c DIRECT 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-05907514643004 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (2)
- EUDAMED 50db0998-91c6-4faa-a448-c2847574c00b 61 fields · synced Oct 6, 2026
- EUDAMED 81b616c7-1658-4664-a2e1-cad5828b0566 61 fields · synced May 19, 2026