OAKMED LTD

Oakmed Ltd specialises in ostomy and wound care products, including accessories. These devices are designed to support skin protection and assist in daily management for patients who require ostomy pouches or wound management solutions. The focus is on improving quality of life for users by offering products tailored to their specific needs.

Oakmed Ltd is based in the United Kingdom. This location places the company within the EU regulatory framework, which governs the classification and compliance requirements for its medical devices.

Oakmed Ltd’s devices are classified under the EU Medical Device Regulation (MDR) as Class I. This classification is typically assigned to low-risk devices, though even Class I products must still meet essential safety and performance requirements to ensure they are safe and effective for their intended use.

Yes, Oakmed Ltd’s devices are registered in eudamed, the European Union’s centralised database for medical devices. Registration in eudamed is mandatory for manufacturers to comply with EU MDR requirements, ensuring transparency and traceability of their products within the EU market.

Class I classification under EU MDR indicates that Oakmed Ltd’s devices are considered low-risk, but they still must comply with essential safety and performance requirements. While some Class I devices may only require general safety controls, others—especially those involving direct contact with skin or bodily fluids—may need additional measures like design controls or risk management to ensure safety and proper functionality.