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St Aia-Pack T4

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 0025258

by Tosoh Corporation

Identity

Trade Name
ST AIA-PACK T4 FDA UDI
Generic Name
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ST AIA-PACK T4 EUDAMED
Model / Reference
0025258 EUDAMED
N/A FDA UDI

Identifiers

Primary DI / UDI-DI
14560189210803 EUDAMEDFDA UDI
Basic UDI-DI
B-14560189210803 EUDAMED
FDA Product Code
KLI FDA UDI
EMDN Code
W01020407 THYROXINE EUDAMED
GMDN Term
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.1700 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

Yes

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 T4 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

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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 8f9ee816-e29f-4df6-a3d1-b552e245b817 61 fields · synced Jul 12, 2026
  • FDA UDI c0059664-c636-427f-b99a-1ce71c53d14f 34 fields · synced May 30, 2026