MR INC.

MR Inc. specializes in manufacturing electromagnetic stimulators, which are designed to deliver controlled electrical impulses for therapeutic purposes. These devices are intended to stimulate muscle or nerve tissue as part of medical treatment.

MR Inc. is based in South Korea, which means its devices must comply with the regulatory requirements of the country where they are marketed. For example, if sold in the EU, they are registered in eudamed, the EU’s medical device registry, as part of the mandatory transparency requirements.

MR Inc.’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices marketed within the European Economic Area. This registration is required under EU regulations to ensure traceability and transparency of medical devices in circulation.

MR Inc.’s electromagnetic stimulators are classified as Class IIa medical devices. This classification indicates they pose a low to moderate risk and require compliance with specific EU regulations, including design controls, risk management, and post-market surveillance, but do not require a clinical investigation or active post-market surveillance plan like higher-risk classes.