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Organization name
UDI-DI code
Reference / catalog number

DT 100 — IVDD — General IVDD by Tcoag ireland ltd

MD Atlas
Tcoag ireland ltd

EUDAMED last updated this device on Feb 1, 2023

DT 100

B-05391521421234

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: 05391521421234
Reference / catalog number: H02000

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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.

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement	May 10, 2010	Still on market
France	May 10, 2010	Still on market

Device identification

Trade name: DT 100
UDI-DI code: 05391521421234
Basic UDI-DI: B-05391521421234
Reference / catalog number: H02000
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: The DT 100 is intended to be used as an automated coagulation analyser for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles and may also be used for chromogenic kinetic enzyme analysis and micro particle agglutination assays.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0299IVD INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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