Ephraim Body Tools BV

Ephraim Body Tools BV specializes in manual medical devices for personal use. Specifically, the company produces the EarScratcher, a device designed to help individuals clean their ear canals by removing earwax or debris without requiring surgical intervention. The product is intended for at-home or self-care use.

Ephraim Body Tools BV is headquartered in the Netherlands. The company’s location in the Netherlands aligns with EU regulatory frameworks, which may influence its device compliance and reporting processes.

The EarScratcher, the primary device produced by Ephraim Body Tools BV, is listed in the eudamed database. This registry is the official EU portal for medical device information, ensuring transparency and traceability of devices under EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).

The EarScratcher is classified as a Class I medical device. This classification is determined based on its intended purpose, risk profile, and the potential harm it poses to users. Class I devices are generally considered low-risk, often involving minimal intervention or non-invasive procedures, and typically require less stringent regulatory oversight than higher-class devices.