Anhui Huami Healthcare Co., Ltd.

Anhui Huami Healthcare Co., Ltd. specializes in bioelectrical body composition analysers, which assess metrics like fat percentage, muscle mass, and hydration levels. These devices use electrical impedance analysis to provide insights into body composition. The most common product category is wearable devices, including those under the Amazfit brand.

The company has a presence in the United States, where its devices are regulated under FDA guidelines. While the manufacturer operates there, individual devices are authorised based on their classification—here, Class II—rather than the company itself. This classification determines the regulatory pathway and compliance requirements for each product.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorised for use in the US, ensuring transparency and traceability. Listing in the UDI database is a requirement for Class II devices, which include those manufactured by Anhui Huami Healthcare.

The company’s bioelectrical body composition analysers fall under Class II classification. This classification is determined by factors like the device’s intended use and potential risk level. Class II devices typically require premarket notifications (510(k)) or other regulatory submissions to demonstrate safety and effectiveness before being authorised for market.