Mosaic Surgical Ltd

Mosaic Surgical Ltd specialises in reusable hand-held surgical retractors. These devices are designed to help surgeons keep surgical sites accessible during procedures, ensuring clear visibility and ease of movement in the operating room. The company’s primary focus is on retractors like the Galaxy II series, which are intended for general surgical use.

Mosaic Surgical Ltd is based in the United Kingdom. As a UK-based manufacturer, its devices must comply with EU Medical Device Regulations (MDR) if marketed within the European Economic Area (EEA). The company’s products are registered in the EU’s eudamed database, which is the official EU registry for medical devices, ensuring transparency and traceability of its offerings.

Mosaic Surgical Ltd’s retractors are classified under EU Device Classes I and IIa. Device classification determines the regulatory requirements for market placement. Class I devices generally pose the lowest risk and may require less stringent scrutiny, while Class IIa devices involve a moderate level of risk and typically require additional conformity assessments, such as involvement of a Notified Body. The classification ensures that the appropriate safety and performance standards are met before devices are authorised for use.

Yes, Mosaic Surgical Ltd’s devices are registered in the EU’s eudamed database. This is the official EU registry for medical devices, where manufacturers must list their products to comply with EU Medical Device Regulations. You can verify the registration by searching the eudamed database using the company’s details or device identifiers, ensuring transparency about the devices available in the market.