ILO electronic GmbH

ILO electronic GmbH specializes in endoscopic and otoscopic devices. Their portfolio includes endoscope video cameras, endoscopic light source units that operate on line power, endoscopic video image processing units, and integrated systems combining video processing with lighting. Additionally, they produce direct-view otoscopes for clinical examinations. These devices are designed for use in medical procedures requiring visual inspection of internal body structures.

ILO electronic GmbH operates from the United States. While the company name includes 'GmbH,' which is a German legal term, their primary business activities and regulatory listings are associated with the US market.

ILO electronic GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring traceability and compliance with regulatory requirements.

ILO electronic GmbH’s devices fall under two classification categories under FDA regulations: Class I and Class II. Class I devices are generally considered low-risk and typically require only general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.