Identity
- Trade Name
- HbA1c EUDAMEDFDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- HbA1c EUDAMED
- Model / Reference
- HBAC-0240 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700821304 EUDAMEDFDA UDI
- Basic UDI-DI
- 37017008HBAC002Q EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
HbA1c by Vitalscientific — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008HBAC002Q | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED d92bc9c7-5d36-46ef-9e7f-b69cbb49aabd 61 fields · synced Jul 14, 2026
- FDA UDI c75f116b-277b-407e-8b4d-3fe80eeb179d 32 fields · synced May 30, 2026