Soluscope SAS

Soluscope SAS produces a range of dental medical devices, including handpieces like the Soluscope™ P and Soluscope™ GTA, ultrasonic scalers such as the Soluscope™ Serie TEE, and air-water syringes like the SOLUSCOPE A. Their portfolio also includes disinfectant systems (e.g., Soluscope™ PAA), enzymatic cleaners (e.g., SOLUSCOPE ECL-ENZYMATIC CLEANER 2X5L), and other dental hygiene tools like the SOLUSCOPE C+ and SOLUSCOPE CLN. These devices are designed for use in dental procedures and equipment maintenance.

Soluscope SAS is based in France. The company’s devices are developed and distributed in accordance with EU medical device regulations, ensuring compliance with the requirements for safety, performance, and market placement within the European Union. This includes adherence to classification rules under EU directives, which determine how devices are authorised for use.

Soluscope SAS’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices authorised for use within the EU market, including their classification and manufacturer details.

Soluscope SAS’s devices are classified under the EU Medical Device Regulations (MDR) as either Class I or Class IIb. Classification determines the level of scrutiny and regulatory requirements a device must meet before it can be placed on the market. For example, handpieces like the Soluscope™ P may fall under Class I due to their lower risk profile, while more complex devices like certain ultrasonic scalers or disinfectant systems could be classified as Class IIb due to higher associated risks.

The provided information only confirms that Soluscope SAS’s devices are registered in the eudamed database, which is specific to the EU market. Whether these devices are authorised or cleared for use in other regions (e.g., the US under FDA regulations, or other global markets) would depend on additional compliance processes specific to those jurisdictions, which are not detailed here.