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TriniLIA D-dimer

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref T3101Model TriniLIA D-dimer

by Tcoag ireland ltd

Identity

Trade Name
TriniLIA D-dimer EUDAMED
TriniLIA™ D-Dimer FDA UDI
Generic Name
D-dimer IVD, kit, agglutination FDA UDI
Device Name
TriniLIA D-dimer EUDAMED
Model / Reference
TriniLIA D-dimer EUDAMED
T3101 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
05391521420572 EUDAMEDFDA UDI
Basic UDI-DI
B-05391521420572 EUDAMED
510(k) Number
K003267 FDA UDI
FDA Product Code
DAP FDA UDI
EMDN Code
W0103020503 D-DIMER EUDAMED
GMDN Term
D-dimer IVD, kit, agglutination FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
864.7320 FDA UDI
Market of Registration
Germany 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

Yes

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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

TriniLIA D-dimer by Tcoag ireland ltd — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Manufacturer's product page: Evaluation of the new Tcoag pre-calibrated assay TriniLIA™ D-Dimer II.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tcoag ireland ltd
EUDAMED SRN
IE-MF-000027371

Sources (2)

  • EUDAMED a4e2587e-d019-4c7c-a0c6-9001b186bd1a 61 fields · synced Jul 21, 2026
  • FDA UDI 115df50d-f455-4b5b-870c-c9f331e2086f 34 fields · synced May 30, 2026