Statistics for Tcoag ireland ltd

64Total Devices

64Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

10Countries

Certificate health for Tcoag ireland ltd

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for Tcoag ireland ltd

Showing 51–64 of 64 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
TriniCLOT Fibrinogen Kit	`T1301`	`05391521420350`	1	On the market
TriniCLOT Imidazole Buffer	`T1901`	`05391521420503`	1	On the market
TriniCLOT Imidazole Buffer	`T1901`	`05391521420503`	1	On the market
TriniCLOT Lupus Confirm	`T1605`	`05391521420480`	1	On the market
TriniCLOT Owrens Buffer	`T1903`	`05391521421210`	1	On the market
TriniCLOT PC II	`T1607`	`05391521421197`	1	On the market
TriniCLOT PS II	`T1608`	`05391521421203`	1	On the market
TriniCLOT PT Excel S 20 mL	`T1103`	`05391521420251`	1	On the market
TriniCLOT PT Excel S 6ml	`T1104`	`05391521420268`	1	On the market
TriniCLOT Thrombin Time 1ml	`T1411`	`05391521420817`	1	On the market
TriniCLOT Thrombin Time 4ml	`T1414`	`05391521420824`	1	On the market
TriniLIA D-dimer	`T3101`	`05391521420572`	1	On the market
TriniLIA D-Dimer II	`T3104`	`05391521421494`	1	On the market
W0103020606	`T1604`	`05391521420473`	1	On the market

1 2 3

Market presence of Tcoag ireland ltd

Devices placed in 10 countries

France14
Ireland13
Germany12
Austria9
Belgium7
Finland3
Spain2
Netherlands2
Denmark1
Italy1

EUDAMED update: Jul 2, 2024

Tcoag ireland ltd

IE-MF-000027371

Active

Address: IDA Business Park, Southern Cross Road, A98 X383 Co. Wicklow
Role: Manufacturer
Date of registration: Aug 15, 2022
Country: IE Ireland

About Tcoag ireland ltd

SRN: IE-MF-000027371
Role: Manufacturer
Country: Ireland
Organization name: Tcoag ireland ltd
EU VAT number: IE9742077F
EORI: IE9742077F
Trade register: 482053
Date of registration: Aug 15, 2022

Contact details for Tcoag ireland ltd

Address: IDA BUSINESS PARK, SOUTHERN CROSS ROAD BRAY A98 X383 CO. WICKLOW IRELAND
Phone: 00353 1 2746614
Email: Pauline.McManus@tcoag.com
Website: https://www.tcoag.com

Validator

Name: Health Products Regulatory Authority, Medical Devices Department
SRN: IE-CA-001
Phone: +353 1 676 4971
Email: devices@hpra.ie

Officers and regulatory representatives of Tcoag ireland ltd

MCMANUS Pauline
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with (d) the reporting vigilance obligations are fulfilled; (e) performance studies referred to in Section 4.1 of Annex XIV
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PRENDERGAST Paula
Regulatory activities: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with (d) the reporting vigilance obligations are fulfilled; (e) performance studies referred to in Section 4.1 of Annex XIV
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MCDONALD Tom
Quality Assurance activities: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with (d) the reporting vigilance obligations are fulfilled; (e) performance studies referred to in Section 4.1 of Annex XIV
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