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PRESTIGE 24i LDL DIRECT
EUDAMEDClass IVD General (EU MDR)
Ref 4-180Model PRESTIGE 24i LDL DIRECTRef 4-490Model PRESTIGE 24i LDL DIRECT
Identity
- Trade Name
- PRESTIGE 24i LDL DIRECT EUDAMED
- Device Name
- LDL DIRECT EUDAMED
- Model / Reference
- PRESTIGE 24i LDL DIRECT EUDAMED4-180 EUDAMED4-490 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514641802 EUDAMED05907514644902 EUDAMED
- Basic UDI-DI
- B-05907514641802 EUDAMEDB-05907514644902 EUDAMED
- EMDN Code
- W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 LDL 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-05907514641802 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (4)
- EUDAMED 6cb65c41-0ab5-4eb0-97ac-b0025580ebcd 61 fields · synced Oct 6, 2026
- EUDAMED 0b57372a-4b6b-44b7-b405-a90dd665f15d 61 fields · synced May 18, 2026
- EUDAMED 72fa2f1d-8419-463e-a7d7-b8e76f0e4282 61 fields · synced Jul 16, 2026
- EUDAMED c163abda-1b8b-435d-bf4a-cdb251390a82 61 fields · synced Jul 17, 2026