EUDAMED update: Jun 3, 2026

RegTrac Limited

IE-AR-000042448

Authorised representativeActive

Address: Workhub, Bracken Road, 51 D18 CV48 Dublin
Role: Authorised representative
Date of registration: Jun 5, 2024
Country: Ireland

RegTrac Limited is an EU authorised representative registered in EUDAMED. Headquartered in Dublin, Ireland. Explore the regulatory profile, devices and certificates on MD Atlas.

About RegTrac

: IE-AR-000042448
Role: Authorised representative
Country: Ireland
Organization name: RegTrac Limited
EU VAT number: IE04269640EH
EORI: NA
Trade register: 759597
Date of registration: Jun 5, 2024

Contact details for RegTrac

Phone: +35315135580
Email: regulatory@reg-trac.com
Website: www.reg-trac.com
Address: 51, WORKHUB, BRACKEN ROAD SANDYFORD BUSINESS PARK, SANDYFORD D18 CV48 DUBLIN IRELAND

Officers and regulatory representatives of RegTrac

AK Ajeena
(a): appropriate check of the conformity of the devices under AR Scope in accordance the QMS (b): drawing up and keeping up to date of the technical documentation and the EU declaration of conformity of devices in scope of AR (c): fulfilment of the PMS obligations in accordance with Article10(10) (d): fulfilment of reporting obligations referred to in Articles 87 to 91 (e): in the case of investigational devices, issuance of the statement referred to in Section 4.1 of Chapter II of Annex XV
Hidden

Competent authority

Name: Health Products Regulatory Authority, Medical Devices Department

Phone: +353 1 676 4971
Email: devices@hpra.ie

Role and obligations in EUDAMED

An authorised representative is an entity established in the European Economic Area that a manufacturer based outside the EEA appoints to act on its behalf for specified regulatory tasks. Registration in EUDAMED is required under Article 11 of the MDR (2017/745) and Article 11 of the IVDR — règlement (UE) 2017/746.

RegTrac Limited

Role and obligations in EUDAMED

Non-EU manufacturers represented

Role and obligations in EUDAMED

Non-EU manufacturers represented