Groupe Servibio

Groupe Servibio specialises in medical devices for blood sampling and specimen collection. Their portfolio includes portable systems like the Easy Para Bailenger, as well as laboratory-use devices such as the Easy Para Check and variants of the Easy Para Servisol series, including the Echantillon Easy Para Servisol. These products are designed to facilitate the collection, handling, and preparation of blood samples for diagnostic or analytical purposes.

Groupe Servibio is based in France. While the company’s location in the EU influences its regulatory framework—such as compliance with EU medical device laws—it does not directly impact the classification or functionality of its devices. The classification of a device (e.g., Class A) is determined by its intended purpose and risk profile, not the manufacturer’s country of origin.

Yes, Groupe Servibio’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This listing confirms that the devices have undergone the necessary regulatory processes, such as conformity assessment, to comply with EU requirements. Listing in EUDAMED ensures transparency for healthcare professionals, regulators, and other stakeholders about the device’s authorised status and compliance with EU medical device regulations.

Groupe Servibio’s devices fall under EU Class A medical device classification. This classification is assigned based on the risk associated with the device’s intended use—Class A devices are considered the lowest risk, typically involving minimal or no invasive procedures. The classification determines the regulatory pathway the device must follow (e.g., self-certification under EU MDR) but does not reflect the device’s performance or safety beyond its risk level.