Identity
- Trade Name
- Hb A1c CAPILLARY CALIBRATORS (2) EUDAMED
- Device Name
- Hb A1c CAPILLARY CALIBRATORS (2) EUDAMED
- Model / Reference
- 4755 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607360047552 EUDAMED
- Basic UDI-DI
- 3607364755BUFD EUDAMED
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
Classification
- Device Class
- Class C 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
Hb A1c CAPILLARY CALIBRATORS (2) by Sebia — Class C — 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 | 3607364755BUFD | Class C | Active |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (1)
- EUDAMED 53ec966e-d30e-44ea-a128-04b8899a5876 61 fields · synced Jul 8, 2026