GA Health Company Limited

GA Health Company Limited specializes in accessories for endoscopic procedures. Their product range includes single-use and reusable items like insufflation tubing sets (both single-use and reusable), endoscope channel support kits, and cleaning utensils. They also produce disposable components such as suction valves, tourniquets, biopsy port adapters, and reusable surgical instrument accessories. Additional offerings include CO₂ tubing adapters, air/water bottle tubing extensions, and protective eyewear designed specifically for endoscopic use.

GA Health Company Limited is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which serves as a centralized registry for tracking medical devices authorized for use in the U.S. This database helps ensure transparency and traceability of their products.

The devices produced by GA Health Company Limited fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and benefits, as outlined in FDA regulations.

The single-use accessories, such as insufflation tubing sets, suction valves, and tourniquets, are designed for one-time use to reduce infection risks and ensure hygiene in endoscopic procedures. Reusable accessories, like endoscope cleaning utensils and certain tubing sets, are engineered for durability and repeated sterilization, providing cost-effective solutions for healthcare settings. Both categories enhance procedural efficiency and safety by supporting proper handling and maintenance of endoscopic equipment.