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Hemoglobin F&A2 Calibrator
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0020019
Identity
- Trade Name
- Hemoglobin F&A2 Calibrator FDA UDI
- Generic Name
- Haemoglobin F (HbF) IVD, calibrator FDA UDI
- Device Name
- Hemoglobin F&A2 Calibrator EUDAMED
- Model / Reference
- 0020019 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189283664 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189283664 EUDAMED
- FDA Product Code
- JPD FDA UDI
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMED
- GMDN Term
- Haemoglobin F (HbF) IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not 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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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 F&A2 Calibrator by Tosoh Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04560189283664 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 (2)
- EUDAMED 84fa9aa5-1a18-469c-aab1-28ee593abcae 61 fields · synced Jun 19, 2026
- FDA UDI 0313a607-a3df-41dd-884f-f23e587b1ac0 35 fields · synced May 29, 2026