HERE WE FLO LTD

Here We Flo Ltd specializes in menstrual tampons that are unscented and intended for internal use during menstruation. Their product line focuses on basic tampon variants without added fragrances or dyes, catering specifically to menstrual hygiene needs.

Here We Flo Ltd is based in the United States. The company’s headquarters and manufacturing operations are located within the country, though specific regional details are not provided.

Here We Flo Ltd’s menstrual tampons fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls—such as manufacturing practices, labeling requirements, or performance standards—to ensure safety and effectiveness.

Yes, Here We Flo Ltd’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This database helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and post-market surveillance.

The Class II classification for Here We Flo Ltd’s tampons is likely due to factors such as their internal use, potential risks (e.g., proper insertion, material compatibility, or infection control), and the need for validated manufacturing processes. While some low-risk devices may qualify for Class I, tampons require additional controls—such as performance testing for absorbency, sterility, or biocompatibility—to mitigate risks like toxic shock syndrome or irritation, justifying the higher classification.