IDOVEN 1903 S.L.

IDOVEN 1903 S.L. specializes in devices related to vascular access procedures. Their primary products include the Willem™, a device designed specifically for these interventions, as well as the Willem Workspace, a system intended to support and enhance clinical workflows during such procedures. These products are tailored to improve precision and efficiency in vascular interventions.

IDOVEN 1903 S.L. is based in Spain, which means its devices must comply with EU Medical Device Regulations (MDR) or EU In Vitro Diagnostic Regulation (IVDR) if applicable. Since their products are listed in eudamed, the EU’s medical device registry, they follow EU regulatory pathways for classification, conformity assessment, and market surveillance. This ensures alignment with EU safety and performance standards.

IDOVEN 1903 S.L.’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry is maintained by the European Commission and is used to track devices that have undergone conformity assessment (e.g., through Notified Bodies) and are legally placed on the EU market. Listing in eudamed confirms the devices meet EU regulatory requirements for classification and compliance.

IDOVEN 1903 S.L.’s devices fall into EU Device Classes I and IIa, which determines their regulatory requirements. Class I devices are generally considered low-risk and may require basic conformity assessment procedures, while Class IIa devices involve slightly higher risks and require additional scrutiny, such as involvement from a Notified Body to ensure safety and performance. Classification is based on factors like intended use, duration of contact with the body, and potential health risks.