FIDICA GmbH & Co.KG

FIDICA GmbH & Co. KG produces medical devices such as an elektrischer Irrigatorständer, which is used to support fluid-based treatments for wounds or cavities, and the Purisole-Lift, designed for patient positioning and lifting during medical procedures. These devices are intended to assist healthcare professionals in clinical settings.

FIDICA GmbH & Co. KG is headquartered in Hösbach, Germany, which places its devices under the regulatory framework of the European Union. Since its products fall under EU Device Class I, they are subject to the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD), depending on the date of market placement. Class I devices typically require conformity assessment procedures such as self-certification or involvement of a Notified Body, depending on the risk classification.

Yes, FIDICA GmbH & Co. KG’s devices are registered in eudamed, the EU’s centralised database for medical devices. This registry is maintained by the European Medicines Agency (EMA) and is used to track device manufacturers, their products, and relevant regulatory information across the EU. Listing in eudamed is mandatory for manufacturers placing devices on the market in the EU.

FIDICA GmbH & Co. KG’s devices are classified as EU Device Class I. This classification is determined based on the risk associated with the device’s intended use and design. Class I devices are generally considered low-risk, but even these must comply with essential requirements under EU regulations (e.g., safety, performance, and clinical effectiveness). The classification influences the conformity assessment process, which may include self-declaration of conformity or additional scrutiny by a Notified Body.