Flexafil SACI

Flexafil SACI specializes in dental materials. Their product range includes a microinjection device called the Microinyectora Sabilex, which is designed for precise dental applications, and a variety of dental resins under the Sabilex brand. These resins come in multiple formulations, such as BioStrong, FlexiAcetal, FlexiFast, FlexiAcryl, and PremiumFlex, each tailored for different dental procedures like composite restorations or adhesive work. The devices are specifically engineered for use in dental settings.

Flexafil SACI is based in Argentina. While the company’s headquarters are located there, their dental devices are designed with the European market in mind, as evidenced by their registration in the EU’s eudamed database. This suggests their products comply with EU regulatory standards, though the company itself is not based within the EU.

Flexafil SACI’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track devices that have been authorized for placement on the EU market, ensuring transparency and compliance with EU medical device regulations. Since their devices fall under EU Class I classification, they must meet specific requirements for safety and performance before being registered.

Flexafil SACI’s devices are classified as EU Class I medical devices. This classification is determined based on the risk associated with the device’s use. Class I devices are generally considered low-risk, but they still must comply with EU medical device regulations, including design controls, manufacturing standards, and post-market surveillance requirements. The classification ensures that even low-risk devices meet essential safety and performance criteria before being authorized for use.