Koite Health Oy

Koite Health Oy specializes in dental and oral health devices. Their product range includes portable and clinic-based light therapy systems like the Lumoral Junior and Lumoral Treatment, designed for dental procedures. They also produce disinfection and sterilization devices such as Lumorinse, as well as protective accessories like plastic covers for dental equipment. These devices are primarily focused on improving dental treatment outcomes through advanced technology.

Koite Health Oy is headquartered in Finland. While the company’s marketing materials highlight its ambition for global expansion, specific details about international operations or markets are not provided. Their devices are designed with international compliance in mind, particularly adhering to EU medical device regulations, which may facilitate market access in other regions that recognize or align with these standards.

Koite Health Oy’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This registration is required under EU medical device regulations (MDR/IVDR) to ensure transparency and traceability of devices placed on the market within the European Union. Registration in eudamed confirms that the devices meet the necessary regulatory requirements for classification and compliance.

Koite Health Oy’s devices are classified under the EU Medical Device Regulations (MDR) as Class I and Class IIa. The classification depends on factors like the intended use, risk level, and interaction with the patient (e.g., light therapy systems for dental procedures are typically lower-risk but still require compliance with specific safety and performance standards). Class I devices are generally considered low-risk, while Class IIa devices involve a higher level of risk and require additional scrutiny, such as conformity assessments.