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Cormay Hdl Direct
EUDAMEDClass IVD General (EU MDR)
Ref 2-179Model CORMAY HDL DIRECT Model CORMAY HDL DIRECT
Identity
- Trade Name
- CORMAY HDL DIRECT EUDAMED
- Device Name
- HDL DIRECT EUDAMED
- Model / Reference
- CORMAY HDL DIRECT EUDAMED2-179 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514621798 EUDAMED
- Basic UDI-DI
- B-05907514621798 EUDAMED
- EMDN Code
- W01010220 LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION 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
Cormay Hdl 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-05907514621798 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (2)
- EUDAMED c1125649-1b4a-408f-8cbd-b5a37520b168 61 fields · synced Jun 18, 2026
- EUDAMED 471ba831-ead5-4ba8-b0fb-a11408542ef7 61 fields · synced Jun 18, 2026