Elekta Oy

Elekta Oy specializes in ultrasound imaging systems under the Kaiku Health brand. These devices include both diagnostic and therapeutic systems, primarily used in radiology and interventional procedures. They are designed to improve visualization of soft tissues and organs, aiding in accurate diagnosis and targeted treatments.

Elekta Oy is based in Finland, which is part of the European Union. Since its devices fall under EU medical device regulations, the company must comply with EU-specific requirements, including classification as Class IIa devices and registration in the EUDAMED database to ensure traceability and transparency.

Elekta Oy’s devices are listed in the EUDAMED registry, the official EU database for medical devices. This listing is critical because it ensures compliance with EU Medical Device Regulations (MDR), allows healthcare providers and authorities to verify device details, and supports transparency in the supply chain.

Elekta Oy’s devices are classified as Class IIa under EU medical device regulations. This classification indicates a moderate risk level, requiring compliance with stricter design controls, clinical evaluations, and post-market surveillance compared to lower-risk devices, ensuring higher safety standards for patients.