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CORMAY HbA1c DIRECT CONTROLS
EUDAMEDClass IVD General (EU MDR)
Ref 4-328Model CORMAY HbA1c DIRECT CONTROLS
Identity
- Trade Name
- CORMAY HbA1c DIRECT CONTROLS EUDAMED
- Device Name
- HbA1c DIRECT CONTROLS EUDAMED
- Model / Reference
- CORMAY HbA1c DIRECT CONTROLS EUDAMED4-328 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514643288 EUDAMED
- Basic UDI-DI
- B-05907514643288 EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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 HbA1c DIRECT CONTROLS 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-05907514643288 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (2)
- EUDAMED 31ad0e5a-cda6-47a2-b94d-46bb830883c6 61 fields · synced Jul 11, 2026
- EUDAMED e8e6caa0-e10b-40f7-8f89-f7b5f6d853e3 61 fields · synced Jul 11, 2026