Hedone USA LLC
Exhibitor
Information
HEDONE USA LLC is a U.S.-based medical technology manufacturer and market-entry partner headquartered in Atlanta, Georgia, USA, specializing in low temperature ethylene oxide (EtO/EO) sterilization systems, environmental emission control, surgical suture manufacturing solutions, hospital air quality systems, and U.S. market access services.We design, manufacture, and supply performance-validated ethylene oxide gas sterilizers for medical device and pharmaceutical manufacturers. Our EtO sterilization systems are engineered for reliable, repeatable, and compliant sterilization of heat- and moisture-sensitive products and are developed in alignment with ISO 11135, ISO 13485, EN 1422, ATEX 2014/34/EU, and 21 CFR Part 11 requirements.
To support environmental compliance, HEDONE USA LLC also manufactures acidic scrubbers that safely neutralize ethylene oxide emissions, ensuring sustainable and regulation-compliant sterilization operations.
Beyond manufacturing, HEDONE USA LLC acts as a U.S. market-entry and distribution partner for international medical device manufacturers. We support FDA registration and listing, regulatory readiness, U.S. importer-of-record services, go-to-market strategy, and distributor development. Through our established healthcare network, we assist qualified manufacturers in navigating Group Purchasing Organization (GPO) pathways, enabling structured access to U.S. hospitals, healthcare systems, and purchasing networks.
Expanding our industrial capabilities, we provide turnkey surgical suture production facility solutions, covering the entire manufacturing workflow from raw material processing to final sterile packaging. Our scope includes polymer extrusion lines (monofilament and multifilament), suture stretching, winding, stiffening, cutting and drying systems; braiding machines; needle manufacturing and precision needle attaching/crimping units; cleanroom systems; glove boxes; dry cabinets; coating and surface treatment processes; primary and secondary packaging solutions including foil and blister packing machines; labeling, sealing, and carton packaging equipment.
These integrated and scalable production lines are designed to support the manufacturing of absorbable and non-absorbable surgical sutures in full compliance with international medical device standards, enabling manufacturers to achieve consistent quality, regulatory readiness, and efficient production throughput.
Recognizing the critical importance of controlled air quality in healthcare environments, HEDONE USA LLC also designs and manufactures hospital-grade HVAC and air purification systems. Our PK-S Series air purifiers, featuring HEPA filtration, UV-C technology, and negative ion generation, are engineered for operating rooms, intensive care units, and isolation rooms.
HEDONE USA LLC supplies a focused portfolio of neurosurgical products supporting cranial, spinal, and neurosurgery care procedures. Our offering includes navigation systems, external ventricular drainage (EVD) systems, shunts, aneurysm and brain clips, dural repair and dural substitute products, and allograft solutions for neurosurgical applications.
Surgical Instruments, Syringe, Catheters, Surgical Sutures (absorbable and non-absorbable), IV Sets and Tubing, Wound Dressings and Bandages, PPE, Gowns and face masks are example products mainly sterilized with ethylene oxide eo eto Sterilizer.
