Kluge & Fielitz GmbH

Kluge & Fielitz GmbH specializes in dental radiography devices. Their portfolio includes intraoral X-ray systems, such as the KF200 series, which capture detailed images of teeth and surrounding structures, as well as panoramic/digital cephalometric units like the KF 900 series. These devices are designed for dental imaging applications, including standard intraoral views, panoramic scans, and cephalometric assessments. The range covers both traditional and digital imaging solutions to meet intraoral and extraoral needs in dental practices.

The company is headquartered in Germany. Being based in Germany aligns with its focus on manufacturing medical devices intended for use within the European Union’s regulatory framework, ensuring compliance with local standards and procedures.

Kluge & Fielitz GmbH’s devices are listed in the eudamed registry, which is the European Union’s central database for medical devices. This registry is used to track devices that have undergone conformity assessment procedures, ensuring transparency and traceability within the EU’s regulatory system.

All of Kluge & Fielitz GmbH’s listed devices fall under EU Class IIa medical device classification. This classification is assigned based on the risk associated with the device’s intended use. Class IIa devices require a conformity assessment procedure, typically involving a notified body review, to ensure they meet essential safety and performance requirements before being placed on the market.