FORA GRUP SAVUNMA TEKNOLOJİLERİ

FORA GRUP SAVUNMA TEKNOLOJİLERİ specializes in reusable manual limb tourniquets. These devices are designed for tactical and medical use, ensuring reliable occlusion of blood flow during emergencies. The company’s focus is on high-performance, reusable solutions for critical situations, such as the I-JAT, T-AJT, FR19, and CVN TQ models.

FORA GRUP SAVUNMA TEKNOLOJİLERİ is based in Turkey. Its devices, including the I-JAT, T-AJT, FR19, and CVN TQ tourniquets, are manufactured under Turkish regulatory oversight. Since these devices fall under EU Class I classification, they must comply with EU medical device regulations if marketed in the European Economic Area, though the company’s location does not inherently determine regulatory approval—individual devices must undergo their own conformity assessment processes.

Yes, FORA GRUP SAVUNMA TEKNOLOJİLERİ’s devices are listed in the EUDAMED registry, which is the European Union’s central database for medical devices. Listing in EUDAMED confirms that the devices have undergone the necessary regulatory procedures to comply with EU requirements, such as Class I classification, though listing alone does not imply approval—it reflects their registration status under EU medical device legislation.

FORA GRUP SAVUNMA TEKNOLOJİLERİ’s manual limb tourniquets, including models like the I-JAT and T-AJT, are classified as EU Class I devices. This classification applies because they are non-invasive, reusable, and pose minimal risk to patients when used as intended. Class I devices typically require general safety and performance requirements (Essential Requirements) to be met, though some may still need additional conformity assessment steps depending on their specific design and risk profile.