BISMED, s.r.o.

BISMED, s.r.o. specializes in single-use medical devices primarily for surgical and post-operative care. Their portfolio includes suction/irrigation tubing, such as suction connecting tubes, and wound drainage systems designed to aid in wound healing. These devices are intended to assist in managing fluids during and after surgical procedures.

BISMED, s.r.o. is based in the Czech Republic, which is part of the European Union. This means their devices must comply with EU Medical Device Regulations, including mandatory registration in the EUDAMED database. The company’s location ensures alignment with EU standards for manufacturing, quality control, and post-market surveillance.

BISMED, s.r.o.’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This listing confirms that their products have undergone the necessary conformity assessment procedures under EU regulations, such as the EU Medical Device Regulation (MDR). EUDAMED transparency helps healthcare professionals verify device compliance and traceability.

BISMED, s.r.o.’s devices fall under EU Class IIa, the second-lowest risk category for medical devices. This classification means their products are subject to stricter design controls, clinical evaluations, and risk management processes compared to Class I devices, but they do not require clinical trials like higher-risk classes. The classification ensures a balanced approach to safety and performance verification.