About Us

Pioneering Excellence in Medical Devices and Environmental Solutions

Welcome to HEDONE USA LLC, a trusted American manufacturer and supplier of advanced medical devices and environmental management solutions, proudly based in Atlanta, Georgia.

At HEDONE USA, we specialize in the design, production, and global distribution of:

- Ethylene Oxide (EtO) Gas Sterilizers ensuring reliable, compliant sterilization of medical devices with precision and safety.
- Acidic Scrubbers for effective emissions control, supporting environmentally responsible sterilization operations.
- Surgical Suture Production Facilities, offering turnkey solutions including clean rooms, suture winding machines, needle attaching units, braiding machines, glove boxes, dry cabinets, and packaging equipment for high-quality, compliant suture manufacturing worldwide.
- Air Purification and Advanced HVAC Devices designed for hospitals and healthcare facilities, improving indoor air quality with HEPA filtration, UV-C disinfection, and precise climate control.
- A broad range of medical equipment, including neuronavigation systems, cranial operations, wound care, surgical operations consumables and disposable products and more, serving hospitals, clinics, and healthcare providers globally.

Regulatory and Market Entry Expertise

HEDONE USA LLC collaborates closely with FDA and MDR regulatory frameworks to ensure that our products and those of our partners meet the highest standards of safety and compliance.

As a market entry liaison, we assist manufacturers in navigating the U.S. healthcare landscape, providing:

- GPO and IDN registration support to facilitate effective sales channels.
- Reimbursement pathway consulting, including RPC evaluation.
- Compliance and market positioning strategy development for U.S. entry.

These services empower our partners to expand efficiently in the U.S. market while maintaining regulatory alignment and operational readiness.

Global Engagement and Growth

HEDONE USA actively participates in MEDICA Düsseldorf, Arab Health WHX Dubai, and FIME WHX Miami, reflecting our commitment to global partnership, innovation, and expanding access to advanced medical and environmental technologies.

Thank you for considering HEDONE USA LLC as your trusted partner in advancing healthcare, environmental safety, and market access worldwide. We look forward to building enduring relationships and supporting your growth with our expertise, integrity, and dedication to excellence.