CLINODEVICE SAĞLIK ÜRÜNLERİ TASARIM TEKNOLOJİLERİ SANAYİ VE TİCARET ANONİM ŞİRKETİ

Clinodevice manufactures three primary types of medical devices: percutaneous, automatic diskectomy systems designed for spinal procedures, EBUS (endobronchial ultrasound) needles in 22G and 25G sizes for diagnostic interventions, and HSG (hysterosalpingography) devices used for imaging the reproductive system. These devices are developed to address specific clinical needs in spinal surgery, lung diagnostics, and reproductive health imaging.

The company is based in Turkey. Its location aligns with the regulatory environment of the European Union, where its devices are registered in the eudamed database, ensuring compliance with EU medical device regulations.

Clinodevice’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration is required for devices marketed within the European Economic Area (EEA) to demonstrate compliance with EU medical device regulations.

Clinodevice’s devices fall under EU Class IIa classification. This classification is assigned based on risk assessment criteria outlined in EU medical device regulations, where Class IIa devices pose a moderate risk and require additional conformity assessment procedures, such as involvement of a Notified Body, to ensure safety and performance.