ECLIPSE MEDTECH LIMITED

Overview

ECLIPSE MEDTECH LIMITED is a company registered in Ireland with CRO number 680642. The company acts as an authorised representative for medical device manufacturers based outside the European Union, facilitating compliance with EU regulations such as the Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). It provides regulatory support, including technical file reviews and communication with the HPRA and other EU competent authorities, to ensure compliance and reduce the risk of devices being removed from the market. The company is linked to Insight Regulatory Consultancy Ltd, a UK-based parent entity offering regulatory affairs, quality assurance, and design services. The business operates as a representative service, not as a direct medical device manufacturer. Information from the website confirms its role in EU regulatory affairs and its experience in handling authorisations and communications. Beyond registry-level identification, no further business details are publicly captured.

Location & registered address

Eclipse Medtech C/o Talent Garden Dublin

Claremont Avenue

Glasnevin

Ireland

Industry classification

NACE Rev. 2 — 46.18

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