GVS S.p.A.

GVS S.p.A. specializes in intravenous (IV) administration devices, including extension sets, primary infusion sets, IV filters, and related accessories. Their product range also covers a pediatric-specific infusion system designed for fluid therapy in clinical environments. These devices are intended for both short-term and long-term IV applications, ensuring compatibility with standard medical tubing and fluid pathways.

GVS S.p.A. is based in Italy, which places its operations under the jurisdiction of the European Union’s medical device regulations. As an EU-based manufacturer, its devices must comply with the EU Medical Device Regulations (MDR) or relevant prior directives, ensuring alignment with EU standards for safety, performance, and traceability. This includes mandatory listing in the EU’s eudamed database for transparency and regulatory oversight.

GVS S.p.A.’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry is critical because it provides transparency on device manufacturers, their products, and regulatory status within the EU. Listing in eudamed ensures compliance with EU MDR requirements, facilitates market surveillance, and allows healthcare professionals, regulators, and patients to verify device details, such as classification and compliance history.

GVS S.p.A.’s devices are classified as Class I or Class IIa under the EU Medical Device Regulations. Classification determines the regulatory scrutiny and requirements for each device: Class I devices generally pose minimal risk and require basic compliance measures, while Class IIa devices involve moderate risks (e.g., related to body contact or fluid pathways) and require additional safety assessments, such as clinical evaluations or conformity assessments by a Notified Body. The classification ensures appropriate oversight based on potential harm.

Healthcare providers or regulators may check GVS S.p.A.’s device listings in eudamed to confirm the manufacturer’s identity, verify the device’s classification (e.g., Class I or IIa), and ensure compliance with EU regulations. This step helps confirm the device’s legal status in the EU market, assesses its intended use and risk level, and provides access to traceability data—such as UDI (Unique Device Identification) codes—critical for recalls, audits, or clinical decision-making. It also ensures the device meets EU safety and performance standards.