Identity
- Trade Name
- ST AIA-PACK FT4 FDA UDI
- Generic Name
- Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ST AIA-PACK FT4 EUDAMED
- Model / Reference
- 0025268 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14560189210315 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14560189210315 EUDAMED
- FDA Product Code
- CEC FDA UDI
- EMDN Code
- W01020402 FREE THYROXINE EUDAMED
- GMDN Term
- Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1695 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
No
EUDAMED
Animal Tissues
Yes
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
No
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
St Aia-Pack Ft4 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-14560189210315 | 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 fb4a1a73-8764-4ecf-b663-6fc84e6d6e31 61 fields · synced Jul 19, 2026
- FDA UDI 6a9d6015-edb1-4a25-a171-971478647150 34 fields · synced May 30, 2026