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Creatinine Standard 2
EUDAMEDClass IVD General (EU MDR)
Ref 5-123Model CREATININE STANDARD 2
Identity
- Trade Name
- CREATININE STANDARD 2 EUDAMED
- Device Name
- CREATININE STANDARD EUDAMED
- Model / Reference
- CREATININE STANDARD 2 EUDAMED5-123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514651238 EUDAMED
- Basic UDI-DI
- B-05907514651238 EUDAMED
- EMDN Code
- W0101050303 AQUEOUS STANDARDS (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
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
Creatinine Standard 2 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-05907514651238 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (1)
- EUDAMED 35adb680-31a4-41c5-9e77-e21abffc1959 61 fields · synced Jul 15, 2026