DFB TECHNOLOGY, LTD

DFB Technology, Ltd specializes in producing glutaraldehyde-based sterilants, such as Aldahol 1.8, which are used specifically for medical device reprocessing. These products are formulated to decontaminate instruments and equipment in healthcare settings, ensuring they meet sterilization standards before reuse.

DFB Technology, Ltd is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

DFB Technology, Ltd’s devices fall under the FDA’s Class II classification. This classification is assigned based on the risk associated with the device—Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.

Yes, DFB Technology, Ltd’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and regulatory oversight.