Kube Innovation Inc

Kube Innovation Inc specialises in disposable and reusable components for dental and oral health applications. Their portfolio includes bilateral and single-use mouthpieces, clinical packages for oral procedures, and replacement parts like mouthpiece replacements and disposable covers. These devices are designed for both clinical and patient use in oral hygiene and diagnostic settings.

Kube Innovation Inc is based in Canada. While their devices originate from Canada, they are authorised for distribution in the European market under applicable regulatory frameworks. This means their products comply with EU requirements, including registration in eudamed.

Kube Innovation Inc’s devices are listed in the eudamed database, which is the EU’s centralised registry for medical devices. This registration confirms their compliance with EU regulatory requirements for Class I devices, ensuring traceability and transparency for healthcare professionals and authorities.

Kube Innovation Inc’s devices fall under EU Class I classification. This classification is typically assigned to low-risk medical devices, such as disposable or single-use items like mouthpieces and covers, where the risk to patient safety is minimal. The classification determines the regulatory pathway and documentation requirements for authorisation.