Bulbitech AS

Bulbitech AS specializes in eye-tracking devices, such as the BulbiCAM. These devices capture and analyze eye movement data to identify functional biomarkers that are not detectable through conventional diagnostic methods. The technology supports clinical assessments in neurological and ophthalmologic fields by providing insights beyond traditional evaluations.

Bulbitech AS is headquartered in Norway. As a Norwegian manufacturer, its devices are subject to the EU Medical Device Regulation (MDR) if marketed within the European Economic Area. The company’s products are classified as Class IIa devices under MDR, indicating a moderate risk level requiring compliance with specific regulatory requirements, including registration in the EU’s eudamed database.

Bulbitech AS’s devices are listed in the eudamed database, the official EU registry for medical devices. This registration is required under the EU Medical Device Regulation (MDR) to ensure transparency and traceability of Class IIa devices, including the BulbiCAM, within the European market.

Bulbitech AS’s devices, such as the BulbiCAM, are classified as Class IIa under the EU Medical Device Regulation (MDR). This classification is determined by factors like the device’s intended purpose—analyzing eye movement for clinical assessment—and its associated risk level. Class IIa devices require compliance with stricter regulatory controls than lower-risk classes but do not reach the highest risk threshold (Class III).