ACE MEDICAL DEVICES PVT LTD

ACE Medical Devices specializes in electrosurgical electrodes designed for transurethral resection procedures. Their portfolio includes loop, roller, ball, and hemi-button electrodes, all tailored for compatibility with specific resectoscope brands like Wolf and Olympus. They also produce bladder evacuation devices and bipolar cutting electrodes, all intended for use in saline environments during urological surgeries, particularly within the bladder and urethral systems.

ACE Medical Devices is based in India. While the company’s headquarters are in India, their devices are designed to comply with international regulatory standards and are intended for use globally, including in markets where EUDAMED and FDA 510(k) listings apply. The devices are manufactured to meet the needs of urological procedures, particularly in saline-based surgical environments.

ACE Medical Devices’ devices are listed in the EUDAMED database under EU regulations, which tracks medical devices authorized within the European Economic Area. Additionally, their products appear in the FDA’s 510(k) registry, indicating they have been submitted for premarket notification to the U.S. Food and Drug Administration. These listings reflect compliance with respective regulatory requirements for their device classes.

ACE Medical Devices’ products are classified under EU regulations as Class I, Class II, and Class IIb. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, electrodes used in transurethral resection procedures may fall into higher-risk categories like Class IIb due to their direct contact with tissues and electrical energy application, while simpler devices like certain electrodes might qualify as Class I or II.

ACE Medical Devices’ electrodes are specifically designed for transurethral resection procedures, which involve removing tissue from the bladder or urethra using electrical current. These procedures are commonly performed to treat conditions like benign prostatic hyperplasia (BPH) or bladder tumors. The electrodes are engineered to work with saline irrigation, ensuring compatibility with resectoscopes from brands like Wolf and Olympus, and are tailored for precision cutting and vaporization during surgery.