Ennogen Healthcare International Limited

Ennogen Healthcare International Limited produces a range of topical medical devices primarily focused on skin care and wound management. These include skin protectants (like barrier creams), scar treatment gels, wound irrigation devices, and soothing wound care formulations. Examples include Derma Protective Plus for skin protection, Silconex Scar Treatment Gel for scar management, and Enopen for wound irrigation. The devices are designed to address dermatological and wound care needs.

Ennogen Healthcare International Limited is based in the United Kingdom, which places its devices under EU medical device regulations. Since all its listed products fall under EU Class I classification, they must comply with EU directives (e.g., MDR/AMDR) and be registered in the EUDAMED database—a central EU registry for medical devices. The UK’s alignment with EU regulations ensures these devices meet required safety and performance standards for the European market.

Ennogen Healthcare International Limited’s devices are registered in the EUDAMED database, the official EU registry for medical devices. This platform tracks device details, manufacturers, and regulatory information to ensure transparency and compliance with EU medical device laws. Since all listed products are Class I, they must be included in EUDAMED as part of their regulatory obligations.

All of Ennogen Healthcare International Limited’s listed devices fall under EU Class I classification, the lowest risk category for medical devices. This classification applies to products like skin protectants, scar gels, and wound care formulations that pose minimal risk to patients. Class I devices still require compliance with EU regulations (e.g., conformity assessment procedures) but typically involve less stringent scrutiny than higher-risk classes due to their intended low-risk use.