ANTONI CARLES S.A.

Antoní Carles S.A. specializes in dental delivery systems, including rotary instruments like the S3 W RC, occlusion sets (e.g., OC-8, OC-12), finishing sets (e.g., IS-1D, IS-600III), and dental tables (ATE-300, ATE-600). These devices are primarily used in dental procedures such as polishing, finishing, and occlusion adjustments, ensuring precision and efficiency in clinical settings.

Antoní Carles S.A. is based in Spain. Its devices are listed in the EUDAQD (eudamed) registry, which is the official European database for medical devices. Listing in eudamed is required for devices placed on the EU market, ensuring transparency and traceability.

The devices produced by Antoni Carles S.A. fall under Class I and Class IIa classifications according to EU medical device regulations. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient. For example, finishing sets (e.g., IS-600III) and rotary instruments (e.g., S3 W RC) are typically lower-risk (Class I), while some specialized tools may require additional scrutiny (Class IIa).

The provided data only confirms that Antoni Carles S.A.’s devices are listed in eudamed, which is specific to the EU market. Whether these devices are also authorised or marketed in other regions (e.g., the US, UK, or globally) is not specified in the available information. Compliance with non-EU regulations would depend on additional authorisations or certifications not mentioned here.