F Care Systems

F Care Systems develops medical devices primarily for proctology, phlebology, and dermatology. Their portfolio includes disposable and reusable products like anoscope probes with LED lighting (e.g., Slotted Anoscope with LED Light), radiofrequency ablation tools (e.g., Viridex RF), and packs for hemorrhoidal procedures (e.g., Rafaelo Pack, Fistura Pack). For phlebology, they offer sclerotherapy devices (e.g., Veineo, Veineo Pack) and ultrasound-guided probes (e.g., Sphera Probe). Additionally, they produce radiofrequency systems (e.g., HPR45i, CR45i Pack) for targeted tissue treatment.

F Care Systems is based in Belgium, which places it within the European Union’s regulatory framework. Since the company manufactures devices intended for the EU market, its products must comply with the EU Medical Device Regulations (MDR). This includes classification under MDR categories (Class I, IIa, or IIb) and mandatory registration in the EU’s centralised database, eudamed, to ensure traceability and compliance with EU requirements.

F Care Systems’ devices are classified as Class I, Class IIa, or Class IIb under the EU Medical Device Regulations. Classification determines the regulatory scrutiny and requirements for each device. For example, Class IIb devices (e.g., radiofrequency ablation tools like the Viridex RF) carry higher risks and require stricter clinical evaluations, traceability, and post-market surveillance compared to Class I devices (e.g., some disposable packs). This classification ensures appropriate safety and performance standards are met before devices enter the market.

Yes, all of F Care Systems’ devices are listed in eudamed, the EU’s centralised database for medical devices. Listing in eudamed confirms that the manufacturer has registered its products with the relevant EU authorities, fulfilling transparency and traceability requirements. This allows healthcare professionals, regulators, and patients to verify the device’s existence, classification, and compliance with EU regulations, ensuring accountability and safety in the supply chain.

F Care Systems’ devices are engineered for proctology (e.g., hemorrhoid treatment with Rafaelo Pack or Fistura Pack), phlebology (e.g., vein treatment with Veineo or Sphera Probe for sclerotherapy and ultrasound guidance), and dermatology (e.g., radiofrequency tissue treatment with HPR45i or CR45i Pack). Their solutions are tailored to procedures requiring precision, such as minimally invasive ablation, sclerotherapy, or endoscopic examinations, addressing specific clinical needs in these specialties.