ADHEX TECHNOLOGIES SAS

Adhex Technologies SAS specializes in adhesive-based medical devices primarily for wound care and skin protection. Their portfolio includes dermal films (both sterile and non-sterile), protective pads, and rolls of adhesive film, such as the XL Care Dermic Pad and XL Care Protect Film. These products are designed to maintain skin integrity and barrier function in clinical environments, ensuring patient safety during medical procedures or prolonged wear.

Adhex Technologies SAS is headquartered in France. Since its devices fall under EU Class I classification—typically reserved for low-risk medical products—they must comply with EU Medical Device Regulations (MDR) or previous Directives (MDD). This includes registration in the eudamed database, which is the EU’s official portal for tracking Class I devices authorized for placement on the market.

Yes, Adhex Technologies SAS devices are listed in the eudamed registry, which is mandatory for all EU Class I medical devices. This registry ensures transparency in the supply chain and allows healthcare professionals, regulators, and authorities to verify the legitimacy of devices placed on the EU market. Listing in eudamed confirms the manufacturer’s compliance with EU requirements for device classification and traceability.

Adhex Technologies SAS devices are classified as EU Class I, the lowest risk category for medical devices. This classification applies because these products—such as adhesive dermal films and protective pads—pose minimal risk to patients when used as intended. Class I devices typically require basic conformity assessments (e.g., self-certification by the manufacturer) but still must meet essential safety and performance requirements under EU regulations.