One Retail Group Limited

One Retail Group Limited manufactures devices under the name ACTIVE ERA, which appear to be a series of medical products. These devices are classified as Class I and Class IIa, indicating they are designed for low to moderate risk applications. The repeated listing of the same product name suggests variations in form or function, but the exact use cases are not specified in the available data.

One Retail Group Limited is based in the United Kingdom. The company’s headquarters or primary operational location is within the UK, though the exact city or region is not provided in the available data.

Yes, One Retail Group Limited’s devices are registered in eudamed, the official EU database for medical devices. This registry is used to track manufacturers, devices, and related information under EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Listing in eudamed is required for compliance with EU regulatory requirements.

One Retail Group Limited’s devices are classified as Class I and Class IIa under EU medical device regulations. Class I devices are generally considered low-risk, often involving simple products like bandages or non-invasive tools, while Class IIa devices pose moderate risk and may require additional safety measures. The classification determines regulatory requirements, such as conformity assessment procedures, labeling, and post-market surveillance.