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Cl Aia-Pack T3 Adjuster Set

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 0029204

by Tosoh Corporation

Identity

Trade Name
CL AIA-PACK T3 ADJUSTER SET FDA UDI
Generic Name
Total triiodothyronine (TT3) IVD, calibrator FDA UDI
Device Name
CL AIA-PACK T3 ADJUSTER SET EUDAMED
Model / Reference
0029204 EUDAMED
N/A FDA UDI

Identifiers

Primary DI / UDI-DI
14562185395454 EUDAMEDFDA UDI
Basic UDI-DI
B-14562185395454 EUDAMED
FDA Product Code
JIT FDA UDI
EMDN Code
W01020405 TRIIODOTHYRONINE EUDAMED
GMDN Term
Total triiodothyronine (TT3) IVD, calibrator FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.1150 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

Yes

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

Cl Aia-Pack T3 Adjuster Set 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 f9470bed-bae7-44ac-8609-630a3b771066 61 fields · synced Jun 19, 2026
  • FDA UDI 701dc6f0-868f-4ce1-8246-8cf64104d741 34 fields · synced May 30, 2026