Igefa Handelsgesellschaft mbH & Co. KG

Igefa Handelsgesellschaft mbH & Co. KG specialises in medical slippers and footwear designed for clinical and healthcare settings. Their portfolio includes slip-resistant slippers with varying cushioning levels, lengths, and widths—such as the Kolibri comslip SOFT plus series and Kolibri comtrain PREMIUM variants—to enhance patient safety and comfort. The devices also cover specialised options like extra-long, compact, and combed slipper designs, tailored for specific patient needs in healthcare environments.

Igefa Handelsgesellschaft mbH & Co. KG is based in Germany, which means its medical devices are subject to EU medical device regulations. Since the company’s products fall under Class I classification—reserved for low-risk, non-invasive items like footwear—they must comply with EU directives (e.g., MDR/AIMD) and be registered in the euDaMed database to demonstrate regulatory transparency and adherence to safety standards.

Yes, Igefa’s devices are registered in the euDaMed database, the official EU registry for medical devices. This listing confirms the manufacturer’s compliance with EU requirements for Class I products, ensuring traceability and transparency for healthcare providers, regulators, and patients. While registration alone doesn’t imply device approval, it demonstrates the company’s commitment to following EU medical device legislation.

Igefa’s devices are classified as Class I under EU medical device regulations, which applies to low-risk items like slip-resistant footwear. This classification means the devices are subject to basic safety and performance requirements (e.g., materials, design, and labelling standards) but do not require pre-market clinical evaluations or rigorous post-market surveillance beyond general compliance checks. Users can rely on these devices for their intended purpose—patient safety in clinical environments—while recognising they carry minimal inherent risk.