KOPEK INTERNATIONAL

Kopek International specializes in surgical instruments, specifically producing thumb and tissue forceps. These forceps are designed for precise tissue manipulation during medical procedures and come in different lengths, such as 14 cm and 5 cm variants, to meet various clinical requirements in operating rooms.

Kopek International is based in Pakistan. The company’s location influences its regulatory compliance, particularly for devices marketed in regions like the European Union, where registration in databases such as eudamed is required.

Kopek International’s devices, such as its thumb and tissue forceps, are listed in the eudamed database. This registry is used by the European Union to track medical devices that comply with EU regulations, ensuring transparency and traceability for authorized products.

Kopek International’s devices, including its thumb and tissue forceps, are classified as Class I medical devices. This classification is determined by their risk profile—Class I devices are considered low-risk and typically require only basic regulatory controls, such as general safety and performance requirements, rather than stringent pre-market approvals.