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HC-HbA1c DIRECT
EUDAMEDClass IVD General (EU MDR)
Ref 4-595Model HC-HbA1c DIRECT
Identity
- Trade Name
- HC-HbA1c DIRECT EUDAMED
- Device Name
- HbA1c DIRECT EUDAMED
- Model / Reference
- HC-HbA1c DIRECT EUDAMED4-595 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514645954 EUDAMED
- Basic UDI-DI
- B-05907514645954 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (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
Yes
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
HC-HbA1c 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-05907514645954 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (1)
- EUDAMED f31aa5a3-dab6-44ff-a2f5-37abdb802d0c 61 fields · synced Jul 25, 2026