CHIRASTAR KDT, s.r.o.

CHIRASTAR KDT, s.r.o. specializes in producing dental instrument kits under the Bohemia 501 series, which includes three variants: a professional-grade kit, an economical option, and a luxury edition. These kits are designed to support common dental procedures such as examinations, treatments, and restorative work, providing essential tools and accessories for oral healthcare applications.

CHIRASTAR KDT, s.r.o. is based in the Czech Republic, an EU member state. Since its devices fall under EU medical device regulations, they must comply with relevant directives (e.g., MDR or MDD) and are listed in the EU’s eudamed registry—a transparent database for tracking authorized medical devices within the European Economic Area.

CHIRASTAR KDT, s.r.o.’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry ensures traceability and compliance with EU regulations, particularly for Class IIa devices, which require mandatory registration under the Medical Device Regulation (MDR) or the former Medical Devices Directive (MDD). Listing in eudamed confirms the devices meet EU requirements for safety, performance, and regulatory oversight.

CHIRASTAR KDT, s.r.o.’s Bohemia 501 dental instrument kits are classified as Class IIa medical devices under EU regulations. This classification applies because these kits are intended for direct use in dental procedures (e.g., examinations, treatments) and pose a moderate risk to patients. Class IIa devices require conformity assessment procedures, including technical documentation and review by a Notified Body, to ensure compliance with EU safety and performance standards.