Uzman Cerrahi Aletler - Özkan Seyhan

Uzman Cerrahi Aletler - Özkan Seyhan specializes in producing surgical instruments under the Uzman brand. Their portfolio includes general-purpose tools like retractors, forceps, scalpels, and clamps, as well as specialized instruments for tissue handling and wound management. These devices are designed for use in surgical procedures across specialties such as orthopedics, general surgery, and gynecology. The range covers both single-use and reusable applications, depending on the specific tool’s intended purpose.

The manufacturer is based in Turkey. Their devices are classified under EU Class I, meaning they are subject to general safety and performance requirements as outlined in the EU Medical Device Regulations. Since these devices are registered in EUDAMED, they comply with transparency obligations under EU law, ensuring their presence in the European market is documented.

Uzman Cerrahi Aletler - Özkan Seyhan’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. Registration in EUDAMED is mandatory for manufacturers to fulfill transparency requirements under EU Medical Device Regulations, particularly for devices marketed within the European Union.

Uzman’s devices are classified as EU Class I, which is the lowest risk category for medical devices. This classification means they are subject to basic safety and performance requirements, including general manufacturing standards, labeling, and risk management. Class I devices typically pose minimal risk to patients and users, requiring less stringent post-market surveillance compared to higher-risk classes.