Identity
- Trade Name
- G8 HbA1c Calibrator Set (S) EUDAMED
- Device Name
- G8 HbA1c Calibrator Set (S) EUDAMEDHemoglobin A1c Calibrator Set EUDAMED
- Model / Reference
- 0023528 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562185403107 EUDAMED
- Basic UDI-DI
- B-04562185403107 EUDAMED45601892100030037C EUDAMED
- EMDN Code
- W0101050302 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
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
G8 HbA1c Calibrator Set (S) 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-04562185403107 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04562185403107 | 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 53506713-4e1c-483d-a098-eec7adadd484 61 fields · synced Jul 14, 2026
- EUDAMED a045b6c1-e808-47f6-9ca3-d946e49a2752 61 fields · synced May 17, 2026