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A-400 Bil Direct
EUDAMEDClass IVD General (EU MDR)
Ref 7-448Model A-400 BIL DIRECT
Identity
- Trade Name
- A-400 BIL DIRECT EUDAMED
- Device Name
- BIL DIRECT EUDAMED
- Model / Reference
- A-400 BIL DIRECT EUDAMED7-448 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514674480 EUDAMED
- Basic UDI-DI
- B-05907514674480 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN 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-400 Bil 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-05907514674480 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (1)
- EUDAMED 4c7ee487-9587-45f3-b50e-ed32442fa17e 61 fields · synced Jul 13, 2026