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HbA1c Enzymatic Calibrator Set
EUDAMEDClass B (EU MDR)
Ref HBAE-0043Ref HBAE-4301Ref HBAE-4303
Identity
- Trade Name
- HbA1c Enzymatic Calibrator Set EUDAMED
- Device Name
- HbA1c Enzymatic Calibrator Set EUDAMED
- Model / Reference
- HBAE-0043 EUDAMEDHBAE-4301 EUDAMEDHBAE-4303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700804604 EUDAMED03701700804611 EUDAMED03701700804628 EUDAMED
- Basic UDI-DI
- 37017008HBAE043A EUDAMED
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
HbA1c Enzymatic Calibrator Set 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 | 37017008HBAE043A | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (3)
- EUDAMED 235a7c56-1054-48ba-b641-bc4ae758de44 61 fields · synced Jul 24, 2026
- EUDAMED e71b8006-95b8-44b0-9a58-d6da251949a3 61 fields · synced May 18, 2026
- EUDAMED 7234b62b-515a-41a9-b9e3-ba1e3973f331 61 fields · synced May 18, 2026