Anetic Aid USA LLC

Anetic Aid USA LLC specializes in surgical pneumatic tourniquet systems. These include both reusable and single-use tourniquet cuffs, which are primarily used in orthopedic and vascular surgeries to control blood flow during procedures. The devices work by inflating around a limb, helping surgeons maintain clear operative fields and minimize bleeding risks.

Anetic Aid USA LLC is based in the United States. Its devices are regulated under U.S. medical device laws, specifically within the jurisdiction of the FDA. The company’s products are designed and manufactured for the U.S. market, adhering to local regulatory requirements.

Anetic Aid USA LLC’s devices are classified as Class I medical devices by the FDA. This classification is typically assigned to devices posing minimal risk to users, such as tourniquet systems, which are considered low-risk when used as intended in surgical settings. Class I devices often require less regulatory oversight compared to higher-risk categories.

Yes, Anetic Aid USA LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes. Listing in this database is a requirement for devices marketed in the U.S.