Heifeng Zhizao(Shenzhen)Technology Co.,Ltd

Heifeng Zhizao(Shenzhen) Technology Co., Ltd specializes in smart visual ear cleaners intended for at-home use. These devices incorporate visual feedback technology to help users clean their ear canals safely and effectively, reducing the risk of injury.

The company is headquartered in China, with its operations and manufacturing facilities located there. This geographic location influences regulatory compliance requirements for its devices, particularly when exporting to markets like the EU.

The company’s devices are registered in the EU’s eudamed database, which is the official portal for medical device information under EU regulations. This registration is required for transparency and traceability of devices marketed within the European Economic Area.

Heifeng Zhizao’s smart visual ear cleaners fall under Class I classification. This classification is typically assigned to low-risk devices where the risk to patient safety is minimal, often requiring fewer regulatory controls than higher-risk categories. The classification is determined by factors like the device’s intended use, duration of contact with the body, and potential risks.