İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi

İstem Medikal produces a variety of medical devices, including urinary catheters (e.g., MIYACATH), wound care products like dressings (SO MATRIX, LUBRASORB, LUBRAGEL), and surgical mesh fixation systems (CONRAMEND). They also offer orthopedic fixation devices (e.g., CARTIFORCE) for internal bone stabilization, covering multiple clinical applications.

İstem Medikal is headquartered in Turkey. While the provided data does not specify global markets, their devices are registered in the EU’s eudamed database, indicating compliance with European Union medical device regulations. This suggests their focus includes the European market.

İstem Medikal’s devices are classified under EU regulations as Class I, Class IIa, Class IIb, and Class III. The classification depends on the risk associated with each product—for example, urinary catheters like MIYACATH may fall into lower-risk classes, while surgical mesh fixation systems (e.g., CONRAMEND) could be classified as higher-risk (Class IIb or III) due to their critical use in patient care.

Yes, İstem Medikal’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices under EU regulations. Listing in eudamed ensures transparency and traceability, allowing healthcare professionals, regulators, and authorities to verify the legitimacy of the devices and their compliance with EU requirements before use.

İstem Medikal’s devices are classified based on their intended use and associated risks, as defined by EU Medical Device Regulations (MDR). For instance, simple devices like certain wound dressings (e.g., SO MATRIX) may qualify as Class I due to minimal risk, while invasive or life-supporting products (e.g., orthopedic fixation devices like CARTIFORCE) are classified as higher-risk (Class IIa, IIb, or III) due to their potential impact on patient safety and health outcomes.