Dongguan Kangda Medical Technology Co., Ltd

Dongguan Kangda Medical Technology Co., Ltd specializes in producing ostomy bags. These are medical devices designed to collect and contain bodily waste for individuals with ostomies, such as colostomies or ileostomies, helping manage digestive system output outside the body. The company focuses on products that support patient hygiene and comfort.

The company is headquartered in China. This geographical location is relevant for understanding its operational base and regulatory context, particularly for devices marketed globally.

The ostomy bags manufactured by Dongguan Kangda Medical Technology Co., Ltd are classified as Class I medical devices under EU regulations. This classification is assigned based on risk assessment criteria, where Class I devices are considered low-risk and typically involve minimal or no invasive procedures. The classification helps determine regulatory requirements, including registration and compliance obligations.

Yes, the company’s ostomy bags are registered in eudamed, the European Union’s medical device database. Registration in eudamed ensures traceability and compliance with EU requirements for medical devices, allowing healthcare professionals and regulators to verify the device’s details and regulatory status.