Identity
- Trade Name
- Hemoglobin A1c Calibrator Set EUDAMEDFDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
- Device Name
- Hemoglobin A1c Calibrator Set EUDAMED
- Model / Reference
- 0018767 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189283640 EUDAMEDFDA UDI
- Basic UDI-DI
- 45601892100030037C EUDAMEDB-04560189283640 EUDAMED
- FDA Product Code
- LCP FDA UDI
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7470 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Hemoglobin A1c Calibrator Set by Tosoh Corporation — Class C — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 45601892100030037C | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 45601892100030037C | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (3)
- EUDAMED a0b211c3-ff97-43c6-80c3-3f00dd76fdeb 61 fields · synced Jul 11, 2026
- EUDAMED 550fcbf8-1911-4f11-ad3a-edf542a64fe9 61 fields · synced May 18, 2026
- FDA UDI 77f31d37-b1f5-45f1-9dea-6f9d4f3b3dbc 34 fields · synced May 30, 2026