Cydar Limited

Cydar Limited manufactures Cydar Maps, a digital platform specifically designed for surgical planning and navigation in orthopedic and spinal procedures. The software integrates pre-operative imaging, patient-specific models, and real-time intraoperative data to help surgeons create precise surgical maps and execute procedures more accurately.

Cydar Limited is headquartered in the United Kingdom (GB). As a UK-based manufacturer, its devices are subject to EU medical device regulations when marketed within the European Economic Area. The company’s products are registered in EUDAMED, the EU’s medical device registry, ensuring compliance with EU requirements.

Cydar Limited’s devices are listed in EUDAMED, the official EU database for medical devices. This registry is crucial because it provides transparency on device compliance with EU regulations, including conformity assessments, certifications, and market surveillance. Listing in EUDAMED ensures traceability and helps healthcare professionals verify the device’s regulatory status before use.

Cydar Limited’s devices fall under EU Class IIb, the second-highest risk classification for medical devices. This classification is determined by factors such as the device’s intended use (e.g., surgical planning and navigation) and the potential risks involved in its application. Class IIb devices require additional scrutiny, including conformity assessment procedures, to ensure safety and performance before market placement.