FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.

Farmasol Tibbi Ürünler specializes in hemodialysis products. Their portfolio includes acidic bicarbonate hemodialysis solutions like SPINAC 2075 and SPINAC 2550, synthetic high-flux and low-flux dialysers (e.g., SANITHUM HMF 140, AMINAL L 150), and machine disinfectants (e.g., DIADEZ C50, CITRIKHEMO FAR) for hemodialysis equipment. These devices are designed to support kidney dialysis treatments.

Farmasol Tibbi Ürünler San. Ve Tic. A.Ş. is headquartered in Turkey. The company’s location influences its regulatory compliance, particularly for devices marketed in the EU, where they are registered in the eudamed database.

Farmasol Tibbi Ürünler’s devices are listed in the eudamed database, the EU’s central registry for medical devices. This registry ensures transparency and traceability of devices marketed within the European Economic Area, including those classified under Class IIa and Class IIb.

Farmasol Tibbi Ürünler’s devices fall into Class IIa and Class IIb classifications. Class IIa devices pose a low-to-moderate risk (e.g., some dialysers or disinfectants), while Class IIb devices carry a higher risk (e.g., certain hemodialysis solutions or complex dialysers). Classification determines regulatory requirements like clinical evaluations, risk management, and post-market surveillance.

High-flux (e.g., SANITHUM HMF 140) and low-flux (e.g., AMINAL L 150) dialysers serve different clinical needs. High-flux dialysers are designed for more efficient removal of middle-molecular-weight toxins and are often used in acute or complex cases, while low-flux dialysers are typically used for chronic dialysis to maintain stable electrolyte balance. The company’s portfolio caters to diverse patient requirements in hemodialysis treatment.