MiyaHealth Pte. Ltd.

MiyaHealth Pte. Ltd. develops the GENSUAPP, a mobile application focused on genetic counseling and hereditary disease risk assessment. It helps users interpret genetic test results and provides evidence-based guidance on potential health risks, functioning as a Class I medical device.

MiyaHealth Pte. Ltd. is based in Singapore. While Singapore has its own regulatory framework for medical devices, the company’s Class I device, GENSUAPP, is also registered in the EUDAMED database, indicating compliance with EU medical device regulations. This dual registration reflects the company’s approach to meeting global standards.

MiyaHealth Pte. Ltd.’s devices, including GENSUAPP, are listed in the EUDAMED database. This registry is critical because it provides transparency on devices authorized in the European Economic Area, helping healthcare professionals, regulators, and patients verify compliance with EU medical device regulations.

MiyaHealth Pte. Ltd.’s devices, such as GENSUAPP, fall under Class I classification in the EU. This classification is the lowest risk tier for medical devices, typically reserved for items like bandages or low-risk software applications. Class I devices still require compliance with EU regulations, including conformity assessment procedures, but generally involve less stringent oversight than higher-risk classes.