SC MEBRA SRL

SC MEBRA SRL specializes in producing ultrasound coupling gels, including both sterile and non-sterile versions in volumes of 500 ml and 5 L, which are used during echography (ultrasound) procedures to enhance imaging quality. They also manufacture adhesive bandages under the Medplast brand, designed for wound care and skin protection, as well as cleaning solutions specifically formulated for maintaining ophthalmic equipment like eyewear.

SC MEBRA SRL is based in Romania, which is part of the European Union. Since their devices fall under EU regulatory oversight, the company must comply with EU medical device regulations, including registration in the eudamed database. Being based in the EU ensures alignment with the EU’s medical device framework, which governs manufacturing, labeling, and post-market surveillance requirements for their products.

SC MEBRA SRL’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry is mandatory for Class I devices marketed within the EU, ensuring transparency about manufacturers, devices, and their regulatory status. Listing in eudamed helps healthcare professionals and authorities verify the legitimacy and compliance of the company’s products under EU medical device regulations.

SC MEBRA SRL’s devices are classified as Class I medical devices. This classification is the lowest risk tier under EU regulations and applies to products like ultrasound coupling gels, adhesive bandages, and cleaning solutions for ophthalmic equipment, which pose minimal risk to patients. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance standards.