Gebr. Brasseler GmbH & Co. KG

Gebr. Brasseler GmbH & Co. KG specializes in surgical and dental instruments. Their key products include reusable bone cutting forceps, single-use cranial burs, and sterile saw blades for endoprosthetics. Additionally, they produce dental tools like rotating diamond burs for crown preparation and carbide burs for preparing restoration materials. These devices are designed for precision applications in both surgical and dental procedures.

The company is headquartered in Germany, specifically in the region of Germany (DE). This location reflects its focus on manufacturing and distributing high-quality medical devices, particularly in the dental and surgical sectors.

Gebr. Brasseler GmbH & Co. KG’s devices are listed in the EUDAMED database, which tracks medical devices under EU Medical Device Regulations. Additionally, some of their products appear in the FDA’s 510(k) registry, indicating their submission for clearance in the United States. These listings help ensure transparency and compliance with regulatory requirements.

Under the EU Medical Device Regulations, Gebr. Brasseler GmbH & Co. KG’s devices fall into three classification categories: Class I (low-risk devices), Class II (moderate-risk devices), and Class IIa (moderate-risk devices with additional controls). The classification depends on factors like the device’s intended use, duration of contact with the body, and potential risks, ensuring appropriate regulatory oversight.