Identity
- Trade Name
- Hemoglobin A1c Control Set EUDAMED
- Device Name
- Hemoglobin A1c Control Set EUDAMED
- Model / Reference
- 0021974 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560189283923 EUDAMED
- Basic UDI-DI
- 45601892100030157K EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Belgium 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
Hemoglobin A1c Control Set by Tosoh Corporation — Class C — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 45601892100030157K | Class C | Active |
| EUDAMED | European Union | CE/IVDD | 45601892100030157K | Class C | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED 7e59333f-2b42-4cb0-8205-d67c31173b60 61 fields · synced Jul 24, 2026
- EUDAMED 3661f085-b069-403f-b13e-01ec1fa09547 61 fields · synced Jul 24, 2026