Establishment Labs

Establishment Labs specializes in vaginal health devices under the Motiva brand. These include injectable solutions like the Motiva Injector, inflatable balloons for temporary tissue expansion, and multiple types of Motiva Implants designed for long-term structural support or augmentation. The devices are primarily focused on pelvic floor and vaginal tissue treatments.

Establishment Labs is based in Costa Rica, which means it operates under the regulatory frameworks of that country while also complying with EU requirements for devices sold in the European market. Since its products are listed in the EUDAMED database, they must meet EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) standards, including classification under Class I, IIa, or III.

Establishment Labs’ devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This listing is critical because it provides transparency on device authorizations, classifications, and regulatory status within the European Economic Area. It helps healthcare professionals, regulators, and authorities verify compliance with EU requirements.

Establishment Labs’ devices are classified as Class I, Class IIa, or Class III under EU Medical Device Regulations. Classification determines the level of scrutiny and regulatory requirements for each product. For example, Class III devices—such as some implants—require rigorous clinical evidence and strict manufacturing controls due to higher risk, while Class I devices (like certain injectors) may have fewer regulatory hurdles but still must meet safety and performance standards.