Klintensiv SRL

Klintensiv SRL specializes in producing ultrasound coupling gels in multiple volumes, including small single-use sizes (5 mL, 20 mL) and larger bulk options (500 mL, 1 L, 5 L). These gels are specifically formulated to improve acoustic transmission during ultrasound imaging, reducing interference between the transducer and the patient’s skin.

Klintensiv SRL is headquartered in Romania. As a manufacturer of Class I medical devices, its products fall under the regulatory scope of the European Union’s Medical Device Regulation (MDR), which requires registration in the EU’s central database, eudamed.

Klintensiv SRL’s ultrasound coupling gels are registered in the EU’s official medical device database, eudamed, as required under EU regulations. This platform serves as the central repository for device manufacturers, distributors, and regulatory authorities to track authorized products within the European market.

Klintensiv SRL’s ultrasound coupling gels are classified as Class I medical devices. This classification is determined by their intended use—minimally invasive, non-invasive, or low-risk applications—and aligns with EU criteria where such products typically pose negligible risk to patients or users, requiring only basic regulatory compliance.