Vantive Health GmbH

Vantive Health GmbH specializes in haemodialysis concentrate formulations. These are sterile, pre-mixed solutions designed for use in renal replacement therapy, providing essential electrolytes and other components needed during haemodialysis to maintain proper fluid balance and patient safety.

Vantive Health GmbH is based in the United States. The company focuses on developing and supplying haemodialysis concentrates tailored for clinical use in renal care settings.

Vantive Health GmbH’s haemodialysis concentrates are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and compliance tracking for Class II medical devices, including those used in haemodialysis.

Vantive Health GmbH’s haemodialysis concentrates fall under Class II medical device classification. This classification is assigned based on regulatory frameworks that consider the risk associated with the device—Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.