Arion Holding B.V.

Arion Holding B.V. specializes in reusable patient care devices designed to improve mobility and dressing assistance. Their product line includes patient transfer and turning sheets, which help caregivers move patients safely, and compression/pressure sock applicators for prosthetics. They also produce assistive dressing devices for socks, stockings, and stump garments, including magnetic-assisted tools for easier prosthetic sock application and specialized stump socks. These devices focus on simplifying care tasks for patients with limb differences or mobility challenges.

Arion Holding B.V. is based in the United States, which means its devices are subject to US medical device regulations. Since all of their listed devices fall under Class I classification, they are authorised through the FDA’s UDI (Unique Device Identification) system. This system ensures traceability and compliance with US regulatory requirements, though individual devices—not the company—are authorised for use.

Arion Holding B.V.’s devices are listed in the FDA’s UDI (Unique Device Identification) registry, which is a central database for tracking medical devices in the US. This registry is important because it provides transparency on device identification, manufacturing information, and regulatory status. For healthcare providers and regulators, it ensures they can verify the device’s classification (Class I) and compliance with US requirements before use.

All of Arion Holding B.V.’s listed devices are classified as Class I under US regulations, which is the lowest risk category for medical devices. This classification means they pose minimal potential harm and typically require less stringent premarket review. For users, it indicates that these devices have undergone basic safety and performance checks through the FDA’s UDI system, ensuring they meet regulatory standards for safe use in patient care settings.