← Back to catalogue
HbA1c Enzymatic
EUDAMEDClass B (EU MDR)
Ref HBAE-M130Ref HBAE-6M30Ref HBAE-7050
Identity
- Trade Name
- HbA1c Enzymatic EUDAMED
- Device Name
- HbA1c Enzymatic EUDAMED
- Model / Reference
- HBAE-M130 EUDAMEDHBAE-6M30 EUDAMEDHBAE-7050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700804406 EUDAMED03701700804420 EUDAMED03701700804437 EUDAMED
- Basic UDI-DI
- 37017008HBAE0134 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
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 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 | 37017008HBAE0134 | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (3)
- EUDAMED 9e38b6b0-744b-4664-ae8d-37ca3081bc6d 61 fields · synced Aug 1, 2026
- EUDAMED 9303cc5c-130e-44e7-9594-1da4fd340070 61 fields · synced May 18, 2026
- EUDAMED 48c32a3d-151b-440d-82f3-64eacec656c8 61 fields · synced May 18, 2026