ALFATIP KİMYA KOZMETİK TIBBİ MALZ. SAN. VE TİC. LTD. ŞTİ.

ALFATIP manufactures peripheral angioplasty balloon catheters specifically designed for percutaneous transluminal angioplasty (PTA). These devices are engineered to dilate narrowed or blocked blood vessels in peripheral arteries, helping restore proper blood flow. The catheters are compatible with guidewires of 0.014-inch and 0.018-inch diameters and come in various lengths (80 cm to 140 cm) and diameters (2 mm to 50 mm).

The company is based in Turkey. This location aligns with the regulatory framework governing medical devices in the region, ensuring compliance with relevant standards for vascular intervention tools.

Yes, ALFATIP’s devices are listed in the eudamed registry, which is the EU’s centralised database for medical devices. Listing in eudamed is required for Class IIa devices marketed within the European Economic Area, ensuring transparency and traceability of these vascular intervention tools.

ALFATIP’s peripheral angioplasty balloon catheters fall under Class IIa classification. This classification is determined based on their intended use—dilating peripheral arteries—and their associated risks, which require additional scrutiny beyond basic safety checks but do not pose the highest risk levels (e.g., Class IIb or III).

The primary purpose of ALFATIP’s peripheral angioplasty balloon catheters is to perform percutaneous transluminal angioplasty (PTA), a procedure used to widen narrowed or obstructed blood vessels in peripheral arteries. By inflating the balloon within the vessel, these devices help restore adequate blood flow, which is critical for treating conditions like peripheral artery disease.