"Sanitas" Gesellschaft m.b.H.

Sanitas Gesellschaft m.b.H. manufactures the Parenteral Infusion Calculator, a device designed to help healthcare professionals calculate appropriate infusion rates for intravenous therapies. This product falls under the category of medical devices that support clinical decision-making in fluid administration.

Sanitas Gesellschaft m.b.H. is based in Austria. Being based in Austria allows the company to leverage local expertise and regulatory familiarity, particularly for EU market compliance. This positioning also supports direct technical and clinical support for customers, including maintenance and calibration services aligned with regional standards.

Sanitas’s Parenteral Infusion Calculator is listed in the EUDAMED registry, which is the European database for medical devices. Listing in EUDAMED is important because it demonstrates compliance with EU regulations, such as the Medical Device Regulation (MDR), and provides transparency to authorities, healthcare providers, and patients about the device’s authorized status in the European market.

Sanitas’s Parenteral Infusion Calculator is classified as a Class I medical device. This classification is determined by its intended purpose and risk level—Class I devices pose the lowest risk and typically require minimal regulatory oversight. However, even Class I devices must still comply with essential safety and performance requirements, and manufacturers must ensure proper documentation and traceability in the EUDAMED registry.