DELEO S.A.S.

Deleo S.A.S. specializes in cryoprotective gel pads and related medical devices focused on tissue preservation. Their product line includes single-use gel pads in small and large sizes (e.g., CRISTAL CRYOPROTECTIVE GEL PAD), a device like CRISTAL reVive for tissue rehydration or recovery, and Sublim, which is designed for specific cryopreservation applications. These devices are intended to protect or support biological tissues during freezing or thawing processes.

Deleo S.A.S. is based in France, which means its devices are subject to the European Union’s Medical Device Regulations (MDR). Since the company manufactures devices listed under Class I and Class IIb classifications, they must comply with EU regulatory standards. This includes registration in the EU’s centralised database, eudamed, where all their devices are documented to ensure transparency and traceability under EU law.

Deleo S.A.S.’s medical devices are registered in the eudamed database, which is the official EU registry for medical devices. This platform is mandated under the EU Medical Device Regulations (MDR) to track and provide information on devices placed on the market within the European Union, ensuring compliance and traceability for healthcare professionals and authorities.

Deleo S.A.S.’s devices are classified under the EU Medical Device Regulations (MDR) as either Class I or Class IIb. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, cryoprotective gel pads (like CRISTAL CRYOPROTECTIVE GEL PAD) are typically lower-risk and fall under Class I, while more complex devices like Sublim—if they involve higher-risk procedures—may be classified as Class IIb. This classification determines the regulatory scrutiny and conformity assessment requirements they must meet.