PulseLavage AB

PulseLavage AB specializes in orthopedic surgical instruments and systems primarily used for joint lavage and preparation. Their portfolio includes retractors, irrigation devices, and channel separators, such as the Motiva® Channel Separator and OrthoLavage system, which are designed for hip procedures like arthroplasty. These tools are intended to reduce infection risk and enhance surgical precision during joint surgeries.

PulseLavage AB is based in Sweden. Their devices are developed and manufactured in accordance with European regulatory standards, including compliance with the Medical Device Regulation (MDR). The company ensures its products meet EU requirements for safety, performance, and quality, as reflected in their registration in the eudamed database.

PulseLavage AB’s devices are classified under EU regulations as either Class IIa or Class III. The classification depends on the risk associated with each product—Class III devices, such as certain lavage systems, carry higher risks and require stricter regulatory oversight, while Class IIa devices, like some retractors, involve moderate risks. This classification determines the level of scrutiny and documentation required for their authorisation.

Yes, PulseLavage AB’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This listing ensures transparency and compliance with the Medical Device Regulation (MDR), allowing healthcare professionals, regulators, and other stakeholders to verify the company’s products and their regulatory status.