DOLGENCORP, LLC

DolgenCorp, LLC produces a variety of medical devices primarily focused on personal hygiene and oral care. Their portfolio includes menstrual hygiene products like unscented and scented tampons and pads, as well as oral health devices such as manual and electric toothbrushes and dental floss. Additionally, they manufacture a rapid in-vitro diagnostic (IVD) kit designed for detecting human chorionic gonadotropin (hCG) in clinical settings, which is used to confirm pregnancy.

DolgenCorp, LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.

DolgenCorp, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices by assigning a unique identifier to each product, which helps in tracking and monitoring devices throughout their lifecycle.

DolgenCorp, LLC’s devices fall under different FDA classification categories depending on their risk level and intended use. Most of their products are classified as Class I, which includes low-risk devices like basic hygiene items. Some devices, such as certain menstrual products or diagnostic kits, may be classified as Class II, requiring additional controls due to moderate risk. A few devices are listed as unclassified (U), meaning they do not fall into the standard Class I, II, or III categories but still meet regulatory requirements.

The unclassified (U) designation in the FDA registry indicates that these devices do not fit neatly into the standard Class I, II, or III risk-based categories. This could be due to unique features, minimal risk, or regulatory pathways that do not require full classification under traditional FDA guidelines. For example, some basic hygiene products may be deemed low-risk enough to operate under general controls without needing specific classification, though they still undergo regulatory oversight to ensure safety and effectiveness.