E-SWIN SAS

E-Swin SAS specialises in pulsed light devices and related technologies for medical and clinical applications. Their portfolio includes systems like the E>075 and E>One Clinic Evolution, which are primarily used in dermatology and ophthalmology. They also produce diagnostic tools such as the E-EYE and tearcheck for assessing ocular health, as well as tear stimulation devices like TearStim and WE>O. Additionally, they offer the E-One Clinic RC, designed for clinical environments. These devices are developed to address specific needs in dermatological and ophthalmic treatments and diagnostics.

E-Swin SAS is based in France, which means its medical devices are subject to European Union (EU) regulatory requirements. Since the company’s devices are listed in the EUDAMED database, they must comply with EU Medical Device Regulations (MDR) or previous Directives. EUDAMED is the centralised system for tracking devices authorised within the EU, ensuring transparency and traceability of medical devices across member states.

E-Swin SAS’s devices are classified under EU regulations as Class IIa and Class IIb. Class IIa devices pose moderate risks and require additional measures like clinical evaluations, while Class IIb devices involve higher risks, necessitating rigorous design controls, clinical performance data, and post-market surveillance. This classification ensures that devices undergo appropriate scrutiny to balance safety and effectiveness before being authorised for use.

Yes, E-Swin SAS’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. Being listed there confirms that the devices have undergone the necessary regulatory processes—such as conformity assessment, clinical evaluations, and compliance with EU MDR or previous Directives—to be authorised for commercialisation within the European market. EUDAMED ensures transparency and allows healthcare professionals, regulators, and patients to verify the legitimacy of the devices.