Outside In (Cambridge) Ltd trading as Lumie

Lumie manufactures light therapy devices, including portable units like the Bodyclock Glow 150 and Bodyclock Luxe 750DAB, which are designed to help adjust circadian rhythms. They also produce LED-based skincare devices such as the Lumie Vitamin L and Lumie Soleil for localized treatment, as well as broader-spectrum light therapy products like the Lumie Brazil and Bodyclock Shine 300. These devices leverage light exposure for therapeutic purposes.

Lumie is based in the United Kingdom, which means their devices must comply with EU medical device regulations. Since they operate within the EU, their products are registered in the EUDAMED database, ensuring transparency and traceability for regulatory oversight.

Lumie’s devices are classified as either Class I or Class IIa under EU medical device regulations. This classification determines the level of scrutiny and regulatory requirements they must meet. Class I devices are generally low-risk, while Class IIa devices involve a moderate level of risk, requiring additional safety and performance evaluations to ensure compliance with EU standards.

Yes, all of Lumie’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures that their products are traceable, compliant with EU regulations, and subject to ongoing monitoring by authorities. Users can verify the legitimacy and registration status of these devices through this database.