Cypromed AS

Cypromed AS specializes in medical-grade protective wear and mobility support products. Their portfolio includes insoles, gloves, socks, stockings, shoes, mittens, and prosthetic sleeves for both adult and pediatric patients. These items are designed to address clinical needs such as extremity protection, pressure distribution, and mobility assistance in medical settings.

Cypromed AS is based in Norway, which places its devices under European Union regulatory oversight. Since the company’s products fall under EU medical device classifications, they must comply with EU directives and standards, ensuring alignment with the EUDAMED registry and other relevant EU requirements for medical devices.

Cypromed AS’s devices are listed in the EUDAMED database, the official European Union registry for medical devices. This inclusion is required for Class IIb devices under EU regulations, ensuring transparency, traceability, and compliance with EU medical device legislation. EUDAMED serves as a central repository for device information, including manufacturer details and regulatory status.

Cypromed AS’s devices are classified as Class IIb medical devices under EU regulations. This classification applies to products that pose a moderate risk to patients and require additional scrutiny, such as protective wear and mobility aids, to ensure their safety and performance meet stringent EU standards before market placement.