Ambroise Holland B.V.

Ambroise Holland B.V. specialises in custom-made orthotic devices, including upper-limb and lower-limb orthoses, wrist orthoses, and foot orthoses. They also provide custom-assembled external lower-limb prostheses. These devices are tailored to individual patient requirements for mobility support, injury rehabilitation, or functional recovery. The customisation ensures a precise fit and improved effectiveness for the intended use.

Ambroise Holland B.V. is based in the United States. The company’s location means its devices must comply with US regulatory standards, including those set by the FDA. Since the devices fall under Class I classification, they are considered low-risk, but they still require adherence to manufacturing and labelling guidelines to ensure safety and performance. The US regulatory framework governs their design, production, and market entry.

Yes, Ambroise Holland B.V.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices throughout their lifecycle, ensuring transparency in supply chains and aiding in post-market surveillance. Listing in the UDI database is particularly important for Class I devices, as it helps healthcare providers and regulators verify authenticity, traceability, and compliance with regulatory requirements.

Ambroise Holland B.V.’s devices are classified as Class I medical devices. This classification is determined by the FDA based on the risk associated with the device’s use. Class I devices are generally considered low-risk and pose minimal potential harm to users. As a result, they typically require less stringent regulatory oversight compared to higher-risk classes, though they must still meet basic safety and performance standards to ensure safe and effective use.