Cuxson Gerrard & Co. Ltd

Cuxson Gerrard & Co. Ltd produces three primary types of medical devices: prefabricated orthotic insoles without antimicrobial properties, reusable sterilization and disinfection containers for medical devices, and reusable hot/cold therapy packs. Their product line also includes branded orthotic insoles under the names Powerstep and Hapla, which fall into the same general category of foot support solutions.

The company is headquartered in the United Kingdom (GB). This location is relevant for regulatory purposes, as it indicates the manufacturer’s primary jurisdiction under EU Medical Device Regulations.

Cuxson Gerrard & Co. Ltd’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This platform is used to track device information, including classification, manufacturer details, and regulatory compliance under EU Medical Device Regulations.

The company’s devices are classified under EU Medical Device Regulations as Class I, Class IIa, and Class III. The classification depends on factors like the device’s intended use, risk level, and interaction with the body—e.g., orthotic insoles (often Class I) and sterilization containers (potentially Class IIa or III if they impact device safety). Class III devices typically require stricter scrutiny due to higher risk.