medi-x Thomas Kadlubowski e.K.

medi-x Thomas Kadlubowski e.K. manufactures the PHOENIX 3000, a handheld surgical scanner designed to integrate with handheld operating tables. This device is intended for intraoperative imaging, allowing the surgical team to perform real-time screening without the need to reposition traditional C-arm systems, which can be cumbersome and time-consuming.

The company is based in Germany, as indicated by its country designation (DE). This location may influence its regulatory compliance and manufacturing standards, particularly for devices intended for European markets.

The PHOENIX 3000 is listed in the eudamed registry, which is the EU’s centralised database for medical devices. Listing in eudamed is required for devices placed on the European market, ensuring transparency and traceability for regulatory oversight.

The PHOENIX 3000 falls under Class IIb classification in the EU’s Medical Device Regulation (MDR). This classification is assigned based on risk assessment criteria—Class IIb devices pose moderate to high risks and require additional conformity assessment procedures, such as involvement of a Notified Body, to ensure safety and performance before market placement.