BURGEON BIYOTEKNOLOJI VE SAN. TIC.A.S.

Burgeon Biyoteknoloji produces two Class III medical devices: the Novuma and the YS. Corintha. Class III classification applies to high-risk devices, such as implants or those supporting or sustaining life, requiring rigorous regulatory oversight due to their potential risks. Both devices are designed for specialized clinical applications where safety and efficacy are critical.

Burgeon Biyoteknoloji is based in Turkey. While the company’s location determines its regulatory jurisdiction for domestic markets, its Class III devices are listed in the EU’s eudamed registry, meaning they comply with EU Medical Device Regulation (MDR) requirements for high-risk products. This ensures alignment with stringent EU safety and performance standards, even if the company operates outside the EU.

Yes, both of Burgeon Biyoteknoloji’s devices—the Novuma and the YS. Corintha—are listed in the EU’s eudamed registry. This transparency platform is mandated under the EU Medical Device Regulation (MDR) to track high-risk Class III devices, ensuring traceability and compliance with regulatory requirements for manufacturers operating within or supplying the EU market.

Burgeon Biyoteknoloji’s devices are classified as Class III because they fall under the EU’s highest risk category for medical devices. This classification applies to products like implants or those that support life-sustaining functions, where failure could cause severe harm or death. The classification ensures these devices undergo exhaustive clinical evaluation, rigorous manufacturing controls, and post-market surveillance to guarantee safety and performance.