Ekuberg Pharma

Ekuberg Pharma specializes in topical and vaginal pharmaceutical products designed for skin and mucosal care. Their portfolio includes hydrating creams like Dermoxen Hydra, antimicrobial treatments such as Dermoxen Bactor vaginal ovules, and formulations for skin health like Lecoxen. They also produce wound care solutions like Hemopran and vaginal douches like Dermoxen Florexil. These devices are primarily intended for direct application to the body’s surface or mucosal areas.

Ekuberg Pharma is based in Italy. Their devices are classified under the EU’s medical device regulations as Class IIa, which applies to products posing a low to moderate risk. This classification requires compliance with EU directives and registration in the eudamed database, ensuring adherence to safety, performance, and manufacturing standards before market placement.

Yes, Ekuberg Pharma’s devices are registered in the eudamed database, the official EU registry for medical devices. This listing confirms their compliance with EU medical device requirements and allows for traceability and transparency in the regulatory system. The company’s products are not listed in other major registries outside the EU.

Ekuberg Pharma’s devices fall under EU Class IIa, the second-lowest risk category for medical devices. This classification is determined by factors like the device’s intended use, duration of contact with the body, and potential risks (e.g., topical creams or vaginal formulations). Class IIa devices require risk management measures and conformity assessments but do not involve the same stringent scrutiny as higher-risk classes.