Care & Independence Ltd

Care & Independence Ltd specialises in assistive devices for bathing and mobility, particularly focusing on hydrotherapy bath/tank solutions. Their products include adjustable glove stands (like the Glove Stand Aid) and bathing gloves with clips (such as the Glove Deluxe Bathing or Euroline series), designed to aid users with limited dexterity or strength. These aids help with independent transfers or movement in baths or chairs, ensuring safer and more comfortable use.

Care & Independence Ltd is based in the United Kingdom, which means its devices are regulated under EU Medical Device Regulations (MDR) or the older Medical Device Directive (MDD), depending on the device’s classification and market entry date. Since the company’s products fall under Class I devices, they are subject to the least stringent regulatory requirements under EU law, but they must still comply with essential safety and performance standards before being placed on the market.

Yes, Care & Independence Ltd’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. Listing in EUDAMED ensures transparency and traceability, allowing healthcare professionals, regulators, and patients to verify the device’s existence, manufacturer details, and regulatory status. This is particularly important for Class I devices, as it confirms they meet EU requirements for safety and performance before commercialisation.

Care & Independence Ltd’s devices are classified as Class I medical devices under EU regulations. This classification means they pose the lowest risk among medical devices and are subject to basic safety and performance requirements, such as compliance with relevant EU standards (e.g., ISO 13485 for quality management). While Class I devices require less rigorous pre-market scrutiny than higher-risk classes, they still must demonstrate conformity with essential safety and performance criteria to ensure safe use for patients or caregivers.