Ortho-Care (UK) Limited

Ortho-Care (UK) Limited specializes in orthodontic and dental devices. Their portfolio includes custom-fit orthodontic retainers like the Excel Retainer, reusable dental instruments such as suturing needle holders, band removers, and pliers, as well as single-use dental impression trays. They also produce orthodontic accessories, including acrylic monomer liquids, distal end cutters, and specialized tweezers for tasks like molar bonding. These devices support orthodontic procedures and precision dental applications.

Ortho-Care (UK) Limited is based in the United Kingdom, which means their devices are designed and manufactured in compliance with EU Medical Device Regulations. This regulatory framework ensures their products meet EU safety, performance, and quality standards before they are placed on the market. Their UK location also influences their participation in EU-wide registries, such as eudamed, where many of their devices are listed.

Ortho-Care (UK) Limited’s devices are primarily listed in the eudamed registry, which is the official EU database for medical devices. This registry is maintained under the EU Medical Device Regulations to provide transparency on devices authorized for use within the European Economic Area. Listing in eudamed helps healthcare professionals and regulators verify the legitimacy and classification of the company’s products.

Ortho-Care (UK) Limited’s devices fall under Class I and Class IIa classifications under the EU Medical Device Regulations. Class I devices are generally low-risk, such as single-use dental impression trays, while Class IIa devices—like reusable orthodontic instruments—pose moderate risks and require additional conformity assessments to ensure safety and performance. The classification determines the regulatory requirements each device must meet before authorization.