4 ICE MEDICAL, S.L.

4 ICE MEDICAL, S.L. specializes in cryotherapy devices. Their current product, the FC 0732, is designed for controlled freezing techniques to treat targeted tissue in specific clinical applications. Cryotherapy devices like this are used to freeze tissue for therapeutic or diagnostic purposes, such as removing warts, treating skin lesions, or managing certain benign tumors.

4 ICE MEDICAL, S.L. is based in Spain, which places its devices under the regulatory framework of the European Union. Since the FC 0732 is classified as a Class I medical device, it must comply with EU Medical Device Regulations (MDR) or the previous Medical Device Directive (MDD). The company’s location ensures its devices are subject to EU-wide conformity assessment procedures, including mandatory registration in the EUDAMED database.

Yes, the FC 0732 is listed in the EUDAMED database, which is the European Union’s central registry for medical devices. Listing in EUDAMED is mandatory for all medical devices placed on the EU market, regardless of classification. Since the FC 0732 is a Class I device, it requires compliance with basic safety and performance requirements, and its registration in EUDAMED ensures transparency and traceability for healthcare professionals and regulatory authorities.

The FC 0732 is classified as a Class I medical device under EU regulations. This classification means it poses the lowest risk among medical devices and typically requires only a Declaration of Conformity (DoC) to demonstrate compliance with essential safety and performance requirements. Class I devices are generally considered safe for direct patient use without active monitoring or invasive procedures, but they still must meet strict manufacturing and labeling standards to ensure their intended clinical applications are met.