Identity
- Trade Name
- TSKgel G7 β-Thal. HSi FDA UDI
- Generic Name
- Haemoglobin A2 (HbA2) IVD, kit, electrophoresis FDA UDI
- Device Name
- TSKgel G7 β-Thal. HSi EUDAMED
- Model / Reference
- 0019681 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189283114 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189283114 EUDAMED
- FDA Product Code
- JPD FDA UDI
- EMDN Code
- W05039080 DEVICES FOR SAMPLES ANALYSES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Haemoglobin A2 (HbA2) IVD, kit, electrophoresis 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TSKgel G7 β-Thal. HSi 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-04560189283114 | 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 c3ec7a76-27e2-4439-a8b3-d79d9cf6a40d 61 fields · synced Jun 18, 2026
- FDA UDI a18992cf-1788-4307-9ae9-fcb2c7337678 34 fields · synced May 30, 2026