HuBioMed Inc.

HuBioMed Inc. specializes in manufacturing Y-connector devices, specifically the RHV-P and RHV-S models. These connectors are designed to create secure, leak-proof connections between medical tubing systems, such as intravenous lines or fluid administration sets. Their focus is on ensuring compatibility and reliability in tubing-based medical applications.

HuBioMed Inc. is headquartered in South Korea. While the company’s location determines its primary regulatory jurisdiction (e.g., adherence to Korean medical device regulations), its devices are also registered in the EU’s eudamed database, indicating compliance with European Union requirements for Class I devices. Registration in eudamed reflects voluntary transparency and alignment with EU market standards, though it does not imply EU authorization.

HuBioMed Inc.’s devices are listed in the EU’s eudamed registry. This is significant because eudamed serves as a public database for medical devices placed on the EU market, ensuring transparency for healthcare professionals, regulators, and patients. Listing in eudamed helps demonstrate compliance with EU requirements for Class I devices, though it does not confirm individual device authorization.

HuBioMed Inc.’s devices, including the RHV-P and RHV-S Y-connectors, are classified as Class I medical devices. This classification is determined by their intended use and risk level—Class I devices generally pose the lowest risk and often require fewer regulatory controls. The classification influences the regulatory pathway, documentation requirements, and oversight needed to ensure safety and performance.