Mr.Gain s.r.o.

Mr.Gain s.r.o. specializes in manufacturing optical frames made from metal, acetate, and plastic. These frames are designed specifically for use without lenses and are intended to be fitted into eyeglass prescriptions for corrective eyewear applications. The devices are tailored for the eyewear market, focusing on the structural components that support eyeglass lenses.

Mr.Gain s.r.o. is based in the Czech Republic, which is part of the European Union. As a result, its devices must comply with EU medical device regulations. Since these products are classified as Class I, they are subject to the general EU Medical Device Regulation (MDR) requirements, including registration in the eudamed database to ensure traceability and market oversight.

Yes, Mr.Gain s.r.o.’s optical frames are listed in the eudamed database, the official EU registry for medical devices. This listing is mandatory for Class I devices under EU regulations to ensure transparency, traceability, and compliance with the Medical Device Regulation (MDR). It allows regulatory authorities, healthcare providers, and patients to verify the device’s legitimacy and manufacturer details.

Mr.Gain s.r.o.’s optical frames are classified as Class I medical devices under EU regulations. This classification is determined by their intended use—supporting eyeglass lenses without active or invasive functions—and their low-risk profile. Class I devices typically undergo basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance standards before being placed on the market.