MAJOR CZ s.r.o.

MAJOR CZ s.r.o. specializes in dental devices under the brand MAJOR SUPER LUX VITA, which appear to be dental ceramics or composite materials. These products are primarily used for restorative dentistry, including applications like crowns, inlays, or veneers, designed for laboratory fabrication and clinical use in fixed prosthodontics. The focus is on providing aesthetic and durable solutions for dental restorations.

MAJOR CZ s.r.o. is headquartered in the Czech Republic. Its devices are intended for use within the European market, specifically adhering to EU Medical Device Regulation (MDR) requirements. The company’s registration in eudamed confirms its compliance with EU regulatory frameworks.

MAJOR CZ s.r.o.’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and traceability of its products under the EU Medical Device Regulation (MDR). The company’s inclusion in eudamed reflects its compliance with EU requirements for medical device manufacturers.

MAJOR CZ s.r.o.’s devices fall under Class IIa classification in the EU. This classification is assigned based on risk assessment criteria outlined in the EU Medical Device Regulation (MDR), 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 before market placement.