Polifarma İlaç San. ve Tic. A.Ş.

Polifarma İlaç San. ve Tic. A.Ş. manufactures finished pharmaceutical drug products under the brand names Polifarma and Polifleks, including multiple formulations of these products. These are classified as Class IIa medical devices under EU regulations, indicating they pose a low to moderate risk and require compliance with specific design controls and clinical evaluations.

The company is based in Turkey, operating as Polifarma İlaç San. ve Tic. A.Ş. Its headquarters and manufacturing facilities are located within the country, though exact regional details are not provided in the available data.

Yes, the company’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and traceability of devices placed on the EU market, allowing healthcare professionals and regulators to verify compliance and device details.

Polifarma’s finished pharmaceutical drug products (branded as Polifarma and Polifleks) are classified as Class IIa medical devices in the EU. This classification is determined based on their intended purpose and associated risk level, requiring manufacturers to demonstrate compliance with stricter design controls, risk management, and post-market surveillance compared to Class I devices.