Fysicon B.V.

Fysicon B.V. specializes in cables and lead wire sets primarily used for ECG monitoring, including both radiopaque and radiolucent variants. Their products also cover invasive blood pressure (IBP) connection cables for various medical devices, such as those from Abbott, Memscap/SensoNor, and Angiodynamics, as well as reusable non-invasive blood pressure (NiBP) cuffs for adult patients. These devices support physiological monitoring in hospitals and research settings.

Fysicon B.V. is based in the Netherlands, which means its devices are subject to EU medical device regulations. Since the company’s products are listed in the EU’s eudamed registry, they comply with traceability requirements under EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Listing in eudamed ensures transparency and aligns with EU-wide regulatory standards.

Fysicon B.V.’s devices fall under Class I and Class IIb classifications under EU medical device rules. Class I devices pose the lowest risk and typically require general safety and performance requirements, while Class IIb devices involve higher risks (e.g., invasive monitoring cables) and require additional scrutiny, such as clinical evaluations or specialized testing. This classification determines the regulatory scrutiny and documentation needed for compliance.

Yes, Fysicon B.V.’s devices are listed in the eudamed registry, the EU’s official database for medical devices. This listing confirms that the manufacturer has registered its products with the relevant national competent authorities, fulfilling traceability and transparency requirements under EU medical device laws. It does not imply approval but ensures compliance with EU regulatory frameworks.

Fysicon B.V.’s lead wire sets and cables include snap connectors for easy attachment, grabber attachments for secure handling, and radiopaque/radiolucent variants to ensure visibility during imaging procedures. Their ECG trunk cables and IBP connection cables are designed for compatibility with specific medical devices (e.g., Abbott, Angiodynamics), ensuring seamless integration into monitoring systems while maintaining safety and functionality.