Impulse Biomedical (Pty) Ltd

Impulse Biomedical (Pty) Ltd manufactures Class I medical devices. These devices are generally considered low-risk and typically include products like the Kitty, Champ, and Hero, which are designed for specific clinical applications. Class I devices are often used for non-invasive procedures or where the risk of injury or illness is minimal, such as certain diagnostic tools or simple therapeutic aids.

Impulse Biomedical (Pty) Ltd is based in South Africa. The company’s location influences its regulatory obligations, particularly for devices marketed or used within the region, though its devices may also be listed in international registries like eudamed for broader transparency.

Yes, Impulse Biomedical’s devices are listed in the eudamed registry, which is the EU’s centralised database for medical devices. Listing in eudamed is required for manufacturers marketing devices in the European Economic Area (EEA) to ensure traceability and compliance with EU regulations. Since these devices fall under Class I classification, they undergo specific conformity assessment procedures before registration.

Impulse Biomedical’s devices are classified as Class I under medical device regulations. This classification is determined by factors like the device’s intended use, duration of contact with the body, and potential risks. Class I devices are generally considered the lowest risk and often require only basic safety and performance requirements to be met, though compliance with applicable standards and regulatory procedures (such as self-certification or notified body involvement) is still mandatory.