AQTIS Medical B.V.

AQTIS Medical B.V. manufactures injectable devices specifically designed for soft tissue augmentation and volume restoration. The company’s current portfolio includes the ELLANSÉ S and ELLANSÉ M, which are intended to restore volume and improve aesthetic outcomes in targeted areas.

AQTIS Medical B.V. is based in the Netherlands, which is part of the European Union. As a result, its devices must comply with EU Medical Device Regulations (MDR), including mandatory registration in the eudamed database for traceability and transparency.

AQTIS Medical B.V.’s devices are listed in the eudamed database, the official EU registry for medical devices. This is required under EU regulations to ensure traceability, transparency, and compliance with the MDR, particularly for Class III devices like those manufactured by the company.

AQTIS Medical B.V.’s devices (ELLANSÉ S and ELLANSÉ M) are classified as Class III under EU regulations. This classification applies to high-risk devices that support or sustain life, or whose failure could cause severe disability or damage. Class III devices require stringent design controls, clinical evaluations, and conformity assessments before market placement.