HUGH STEEPER LIMITED

Hugh Steeper Limited specializes in non-customized finishing components for external limb prostheses. Their product range includes myoelectric and body-powered elbow prostheses, passive hand prostheses, split-hook/specialized-tool hand prostheses, silicone and PVC gloves for prosthetic limbs (adults and youth), and split-toe silicone components for foot prostheses. These devices are designed to enhance functionality and comfort for users.

Hugh Steeper Limited is based in the United Kingdom. The company’s location in the UK influences its regulatory compliance, particularly under EU frameworks like EUDAMED, though individual devices must still meet their respective regulatory requirements for authorization.

Hugh Steeper Limited’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system in the United States. These listings help ensure traceability and compliance with regulatory requirements for Class I devices in both regions.

Hugh Steeper Limited’s devices are classified as Class I under both EU and US regulatory frameworks. Class I devices are generally considered to pose the lowest risk and often require less stringent regulatory oversight, though they still must comply with applicable safety and performance standards before being authorized for market placement.