Identity
- Device Name
- ST AIA-PACK iFT3 EUDAMEDST AIA-PACK iFT3 CALIBRATOR SET EUDAMED
- Model / Reference
- 0025231 EUDAMED0025331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14560189213002 EUDAMED04560189213029 EUDAMED
- Basic UDI-DI
- B-14560189213002 EUDAMEDB-04560189213029 EUDAMED
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ST AIA-PACK iFT3 by Tosoh Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-14560189213002 | 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 0cd99a58-7a46-4fc3-b881-815fa58dc5d3 61 fields · synced Aug 1, 2026
- EUDAMED aae1cc29-bb9a-4890-9a62-563f12e298f9 61 fields · synced May 18, 2026