ZOE MEDSOLUTIONS L.L.C-FZ

Zoe MedSolutions specializes in compression and pressure garments, including reusable and single-use products. Their portfolio covers abdominal girdles (such as front-hook, front-zippered, and reinforced designs), post-operative bras, and thigh-high anti-embolism stockings. These devices are designed to provide medical support, often for post-surgical recovery or circulation assistance.

Zoe MedSolutions is based in the United Arab Emirates. While the company’s location determines its regulatory jurisdiction, the devices themselves are classified under EU medical device regulations (Class I) and are registered in the EUDAMED database, ensuring compliance with European standards for medical devices.

Zoe MedSolutions’ devices are listed in the EUDAMED database, which is the European Union’s transparency platform for medical devices. This registry tracks authorized devices within the EU market, ensuring traceability and compliance with regulatory requirements.

All of Zoe MedSolutions’ devices fall under Class I classification, which is the lowest risk category in the EU medical device hierarchy. This classification applies to items like compression garments, post-op bras, and anti-embolism stockings, which are considered low-risk and typically require minimal regulatory oversight beyond basic safety and performance standards.