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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

TriniLIA D-dimer — IVDD — General IVDD by Tcoag ireland ltd

MD Atlas
Tcoag ireland ltd

EUDAMED last updated this device on Jan 4, 2023

TriniLIA D-dimer

B-05391521420572

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Tcoag ireland ltd
UDI-DI code: 05391521420572
Reference / catalog number: T3101

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Manufacturer information

Organization name: Tcoag ireland ltd
SRN: IE-MF-000027371
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

CW106
EUDAMED did not publish a description for this code.
CW074
EUDAMED did not publish a description for this code.
CW103
EUDAMED did not publish a description for this code.
CW104
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW090
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: TriniLIA D-dimer
UDI-DI code: 05391521420572
Basic UDI-DI: B-05391521420572
Reference / catalog number: T3101
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: TriniLIA D-Dimer kit is a polystyrene, microparticle, agglutination assay for the quantitative determination of fibrin degradation products containing D-Dimer in citrated human plasma using automated coagulation analyzers.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103020503D-DIMER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification