Θ.ΚΑΖΑΝΤΖΙΔΗΣ ΑΕ - MEDIPAC

Θ.ΚΑΖΑΝΤΖΙΔΗΣ ΑΕ - MEDIPAC specializes in the PROFIMED device, which is designed for high-risk medical applications. Based on the provided summary, this includes advanced solutions for wound management or infection control, where precision and reliability are critical to patient care. The device is tailored to meet specific clinical needs that demand rigorous performance standards.

The company is headquartered in Greece, as indicated in the provided details. This location is relevant for understanding its regulatory context, particularly in relation to EU Medical Device Regulation (MDR) compliance.

The PROFIMED device manufactured by Θ.ΚΑΖΑΝΤΖΙΔΗΣ ΑΕ - MEDIPAC is registered in the euDAMED database. This registry is part of the EU’s transparency framework under the Medical Device Regulation (MDR), ensuring visibility of devices that comply with EU requirements. Registration in euDAMED is mandatory for devices placed on the market within the EU.

The PROFIMED device falls under Class III classification in the EU regulatory framework. This classification is reserved for the highest-risk medical devices, such as those involved in sustaining life, supporting vital functions, or presenting a risk of severe disability if they fail. Class III devices require comprehensive conformity assessment procedures, including clinical evaluations and rigorous documentation, to ensure safety and performance before market authorization.