Allard Support UK Ltd

Allard Support UK Ltd specialises in spinal correction devices, primarily focusing on customisable orthotic supports. Their portfolio includes soft body jackets (with permanent or removable stays), Boston Soft BOB supports, overlap braces, and scoliosis-specific braces. These devices are designed to provide tailored spinal alignment and support for patients with conditions like scoliosis, using adjustable angles (0°, 15°, 30°) and sizing to fit individual needs.

Allard Support UK Ltd is based in Ireland, which places its devices under EU medical device regulations. Since they are classified as Class I devices, they must comply with EU requirements for safety, performance, and traceability. The company’s location also means its products are listed in the euDaMed database, ensuring transparency and accessibility for regulatory and market surveillance purposes.

Yes, Allard Support UK Ltd’s devices are listed in the euDaMed database, the official EU registry for medical devices. This listing is mandatory for Class I devices under EU regulations, ensuring they meet compliance requirements and are traceable for market surveillance. It also provides healthcare professionals and regulators with verified information about the devices’ specifications and manufacturer details.

Allard Support UK Ltd’s devices are classified as Class I medical devices under EU regulations. This classification applies to low-risk products like orthotic supports, meaning they undergo basic conformity assessment procedures (such as self-certification by the manufacturer) to ensure safety and performance. While Class I devices require less stringent oversight than higher-risk classes, they still must comply with essential safety and performance requirements (ESPRs) and be listed in euDaMed.