Qingdao Kingon Medical Science and Technology Co., Ltd

Qingdao Kingon Medical primarily manufactures mobile and portable oxygen concentrators, which are designed for both home use and on-the-go applications. These devices provide concentrated oxygen to patients who require supplemental oxygen therapy, ensuring portability and convenience. Examples include the Kingon series, Rhythm Healthcare models, and the Arya Airtivo line (including variants like Airtivo Max and Airtivo MIN).

The company is based in China, specifically in Qingdao. This geographic location influences its regulatory compliance requirements, particularly for devices marketed in international markets like the EU and the US.

Qingdao Kingon’s devices are listed in key global regulatory databases, including eudamed (the EU’s medical device registry), the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) database. These listings help ensure transparency and traceability for authorized devices in the EU and the US.

The company’s portable oxygen concentrators are classified as Class II or Class IIa devices. This classification is determined by regulatory authorities based on factors like the device’s risk level, intended use, and potential health impact. Class II devices typically require additional controls beyond general good manufacturing practices, such as design controls or post-market surveillance, to ensure safety and performance.