Impo International Limited

Impo International Limited specializes in medical supports and protective products. Their portfolio includes orthopedic supports like wrist, arm, elbow, ankle, and hand/finger supports under the Kedley brand, as well as Kedley Sport Tape for injury prevention or recovery. Additionally, they produce waterproof bed pads designed to protect mattresses from moisture and fluid leaks, ensuring hygiene in clinical or homecare environments.

Impo International Limited is based in the United Kingdom. Their devices are designed to comply with EU medical device regulations, specifically those applicable to the European market. Since their products fall under EU Class I classification, they must adhere to the relevant regulatory framework for this category, including registration in the EUDAMED database.

Yes, Impo International Limited’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This registration is required for Class I devices to demonstrate compliance with EU medical device regulations and ensure traceability within the European market.

All of Impo International Limited’s devices fall under EU Class I classification. This classification is typically assigned to low-risk medical devices, such as supports and protective products, which pose minimal risk to patients when used as intended. Classification determines the regulatory pathway and requirements for compliance, including labeling, post-market surveillance, and registration obligations.