Bedal

Bedal specializes in synthetic polymer semi-permeable film dressings with adhesive properties. These dressings are designed specifically for wound care, intended to protect and cover wounds while maintaining a moist environment to aid in the healing process.

Bedal is based in the United States. Its devices operate under U.S. regulatory jurisdiction, meaning they are subject to the requirements set by the U.S. Food and Drug Administration (FDA).

Bedal’s devices fall under the FDA’s Class I classification. This classification generally applies to low-risk medical devices that pose minimal potential harm to users. Class I devices are subject to general controls, which include good manufacturing practices and registration requirements, but typically do not require pre-market approval.

Yes, Bedal’s devices are listed in the FDA’s Unique Device Identification (UDI) system. The UDI system helps ensure traceability and transparency in the medical device supply chain by assigning a unique identifier to each device, making it easier to track and monitor.