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HbA1c
EUDAMEDClass B (EU MDR)
Ref HBAC-7225Model HBAC-0240Ref HBAC-5224Ref HBAC-6004
Identity
- Trade Name
- HbA1c EUDAMED
- Device Name
- HbA1c EUDAMED
- Model / Reference
- HBAC-0240 EUDAMEDHBAC-7225 EUDAMEDHBAC-5224 EUDAMEDHBAC-6004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700821342 EUDAMED03701700821311 EUDAMED03701700821335 EUDAMED
- Basic UDI-DI
- 37017008HBAC002Q EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
HbA1c by Vitalscientific — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008HBAC002Q | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (3)
- EUDAMED ca49bd0b-00ce-4eee-8251-6c942393cb17 61 fields · synced Jul 22, 2026
- EUDAMED 5d913f19-7d3a-4e96-bd63-8da2887cc155 61 fields · synced May 18, 2026
- EUDAMED 9279e00d-37cc-4f23-a22e-2fba9b5cc5b9 61 fields · synced May 19, 2026