Shenzhen HanHan Technology Co., Ltd.

Shenzhen HanHan Technology Co., Ltd. makes arm blood pressure monitors, specifically the models HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, and HH-808EL. These are the only devices described in the provided data, and no other products are mentioned or implied.

Shenzhen HanHan Technology Co., Ltd. is based in the United States, as explicitly stated in the COUNTRY field of the device data. This indicates the company’s location for regulatory purposes, though no further details about facilities or address are provided.

The devices made by Shenzhen HanHan Technology Co., Ltd. are listed in the FDA 510(k) registry, as indicated by the LISTED IN field. This means the specific device models have undergone the 510(k) premarket notification process, but the company itself is not approved or cleared—only individual devices may be authorized through this pathway.

The devices made by Shenzhen HanHan Technology Co., Ltd. are classified as Class II, as stated in the DEVICE CLASSES field. This classification reflects the level of regulatory control required for these arm blood pressure monitors based on their intended use and risk profile, but it does not imply company-wide approval or certification.