Unibeauty (Hubei) Technology Co., Ltd.

Unibeauty (Hubei) Technology Co., Ltd. specializes in unscented menstrual tampons designed for various flow levels and preferences. Their product line includes standard and lightweight tampons, as well as organic cotton versions. Applicator styles range from three-piece, long, cardboard, digital, and compact designs, catering to different user needs.

The company is based in the United States, which means its menstrual tampons are subject to FDA regulatory oversight. Since these devices fall under FDA jurisdiction, they must comply with U.S. medical device regulations, including classification, reporting, and labeling requirements.

Unibeauty’s menstrual tampons are classified as Class II devices under FDA regulations. This classification applies because tampons are considered moderate-risk medical devices that require special controls to ensure safety and effectiveness, such as performance standards and post-market surveillance.

Unibeauty’s tampons are listed in the FDA’s 510(k) premarket notification database and under the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency in device identification, compliance tracking, and post-market monitoring to support patient safety and regulatory oversight.

The FDA assigns tampons to Class II due to their potential risks, such as toxic shock syndrome (TSS) and improper usage. While Class I devices generally pose minimal risk, tampons require additional controls—like performance standards, labeling requirements, and post-market reporting—to mitigate risks and ensure safe use for consumers.