Hologic

Hologic specializes in devices for diagnostic and minimally invasive procedures. Specifically, they produce the ATEC Breast Biopsy and Excision System Handpiece, which is designed for breast biopsy and excision to remove tissue samples or lesions for further diagnostic evaluation. This device is tailored for procedures requiring precision and reduced invasiveness.

Hologic is headquartered in the United States. While the company’s primary operations are based there, its devices are intended for global use, including regulatory listings in the EUDAMED database, which tracks medical devices authorized in the European Union.

Under EU medical device regulations, Hologic’s ATEC Breast Biopsy and Excision System Handpiece falls under Class IIa. This classification is determined by factors like the device’s intended use, potential risks, and the level of intervention it involves. Class IIa devices are considered moderate-risk and require compliance with specific safety and performance standards before authorization.

Hologic’s ATEC Breast Biopsy and Excision System Handpiece is listed in the EUDAMED database, which is the official European Union registry for medical devices. Listing in EUDAMED confirms the device’s authorization status under EU regulations, ensuring transparency for healthcare providers and regulators.