Identity
- Trade Name
- HbA1c Diluting Solution EUDAMED
- Device Name
- HbA1c Diluting Solution EUDAMED
- Model / Reference
- 0023503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562185400571 EUDAMED
- Basic UDI-DI
- B-04562185400571 EUDAMED45601892100030167M EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMEDW0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Belgium 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 Diluting Solution by Tosoh Corporation — Class IVD General — 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 | B-04562185400571 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04562185400571 | Class IVD General | 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 5af71f45-fbb0-4f0f-ae2a-e3b37e57301f 61 fields · synced Jul 12, 2026
- EUDAMED bf7ef508-ebda-4d59-94aa-082c008a7ac4 61 fields · synced May 19, 2026