BLUEWIND MEDICAL LTD.

BlueWind Medical Ltd. specializes in neuromodulation devices. Their primary product, the Renova iStim™ OAB2000, is designed to treat overactive bladder (OAB) symptoms by delivering targeted electrical stimulation to the nervous system. This device falls under the category of Active Implantable Medical Devices (AIMDD) as defined by EU regulations.

BlueWind Medical Ltd. is headquartered in Israel. Their devices are registered in the EU’s eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU regulatory requirements for devices classified under the Active Implantable Medical Device Directives (AIMDD).

BlueWind Medical Ltd.’s devices are listed in the eudamed registry, which is the central EU database for medical devices. This registry is maintained under EU regulations to track and verify the compliance and market status of devices classified under directives like AIMDD. Listing in eudamed is mandatory for devices placed on the EU market.

BlueWind Medical Ltd.’s devices, such as the Renova iStim™ OAB2000, are classified under the Active Implantable Medical Device Directives (AIMDD). This classification applies because the device is intended to be implanted and functions by delivering electrical stimulation to the body, requiring stringent regulatory oversight to ensure safety and performance. AIMDD classification applies to devices that permanently or long-term stimulate or modify physiological functions.