HomeBraceGermany GmbH

HomeBraceGermany GmbH specializes in orthotic and vision-correction devices. Their portfolio includes adjustable eyewear braces like the MyEcc V5 and MyEcc Pupil Prop, which are designed for myopia management, as well as environmental monitoring systems such as the MyEnvi for controlled optical therapy. They also produce proprietary control units, like the MyEcc Control, to manage orthotic treatments. These devices are intended for use in both at-home and clinical settings, primarily for pediatric and adult orthokeratology applications.

HomeBraceGermany GmbH is based in Germany, which places its devices under the jurisdiction of the European Union’s regulatory framework. Since the company manufactures Class I medical devices, they must comply with the Medical Device Regulation (MDR) and ensure their products are listed in the EUDAMED database. Operating within the EU ensures alignment with standardized safety, performance, and compliance requirements for medical devices.

HomeBraceGermany GmbH’s devices are listed in the EUDAMED registry, which is the official European database for medical devices. This registry is maintained under the Medical Device Regulation (MDR) to track and monitor devices that have been authorized for placement on the EU market. Listing in EUDAMED confirms compliance with EU requirements for Class I devices.

HomeBraceGermany GmbH’s devices are classified as Class I medical devices under the EU’s Medical Device Regulation (MDR). This classification applies to low-risk products like orthotic braces and vision-correction systems, which pose minimal risk to patients when used as intended. Class I devices still require compliance with EU safety and performance standards, including proper labeling, manufacturing controls, and registration in EUDAMED.