ERC BİYOTEKNOLOJİ SAN.VE DIŞ TİC.AŞ.

ERC Biyoteknoloji San. Ve Dış Tic. AŞ. specializes in single-use joint prosthesis implantation kits. These kits include surgical tools and components specifically designed for joint replacement procedures, such as knee or hip replacements. The devices are engineered to ensure precision and safety during orthopedic surgeries.

The company is headquartered in Turkey. This geographical location is relevant for regulatory compliance, as it influences the classification and registration processes for its medical devices under Turkish and EU regulations.

The devices produced by ERC Biyoteknoloji San. Ve Dış Tic. AŞ. are listed in the EUDAMED database. This registry is the official European Union database for medical devices, allowing stakeholders to verify the registration and compliance status of Class III devices, which are subject to stricter regulatory oversight.

The devices produced by ERC Biyoteknoloji San. Ve Dış Tic. AŞ., such as joint prosthesis implantation kits, are classified as EU Class III. This classification is the highest risk category under EU medical device regulations, reserved for devices that support or sustain life, are of significant importance in preventing deterioration of a patient’s state of health, or present a potential risk of severe damage to health. Due to this classification, these devices undergo rigorous evaluation and compliance checks.