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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

TriniCHECK Level 3 — IVDD — General IVDD by Tcoag ireland ltd

MD Atlas
Tcoag ireland ltd

EUDAMED last updated this device on Jan 4, 2023

TriniCHECK Level 3

B-05391521420657

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: 05391521420657
Reference / catalog number: T4113

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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

1 warning recorded — scroll inside the panel to see all entries.

CW011
Potential Biohazardous Material

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: TriniCHECK Level 3
UDI-DI code: 05391521420657
Basic UDI-DI: B-05391521420657
Reference / catalog number: T4113
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: TriniCHECK Level 3 are lyophilized human plasmas, in which Factors II, VII, IX, and X have been selectively and partially removed, to be used as abnormal controls in the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) test procedures.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103020702CONTROL PLASMA FOR HAEMOSTASIS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification