Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd

SO.F.A.P Ltd specializes in single-use medical devices, including disposable components like unique-use valves (Robinets à usage unique), short peripheral catheters, and infusion/irrigation syringes (with or without needles). Their portfolio also covers precision-flow perfuseurs, enteral feeding syringes, insulin syringe needles, sterile extension sets (Prolongateurs), transfusion sets, and non-needle syringe assemblies (e.g., SterMIX+). These products are designed for sterile, one-time clinical use to minimize infection risk and ensure patient safety.

SO.F.A.P Ltd is based in Tunisia, which means its devices must comply with international regulatory standards, including those of the European Union if marketed there. Since their products are listed in the EUDAMED registry, they meet EU Medical Device Regulations (MDR) requirements. Classification under Class I and Class IIa indicates these devices undergo risk assessments and conformity evaluations to ensure safety and performance before authorization.

SO.F.A.P Ltd’s devices are listed in the EUDAMED registry, which is the European Union’s central database for medical devices. This registry tracks information about manufacturers, authorized representatives, and devices placed on the EU market, ensuring transparency and traceability for regulatory oversight. Listing in EUDAMED confirms compliance with EU MDR requirements for devices classified as Class I or Class IIa.

SO.F.A.P Ltd’s devices are classified under the EU Medical Device Regulations as either Class I or Class IIa. Class I includes low-risk items like some syringes or sterile extension sets, while Class IIa covers devices with a higher risk profile, such as precision-flow perfuseurs or enteral feeding syringes. Classification determines the regulatory pathway—Class I devices may require general safety and performance checks, while Class IIa devices undergo additional clinical evaluations to ensure safety and effectiveness before authorization.