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A-800 Ldl Direct
EUDAMEDClass IVD General (EU MDR)
Ref 7-816Model A-800 LDL DIRECT
Identity
- Trade Name
- A-800 LDL DIRECT EUDAMED
- Device Name
- LDL DIRECT EUDAMED
- Model / Reference
- A-800 LDL DIRECT EUDAMED7-816 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514678167 EUDAMED
- Basic UDI-DI
- B-05907514678167 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
A-800 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-05907514678167 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (2)
- EUDAMED 9efa52a4-546e-4d4c-b180-7a2436db62d4 61 fields · synced Jul 10, 2026
- EUDAMED a20bbf2b-50a5-467d-b3b1-2c8d1b9757a6 61 fields · synced Jul 10, 2026