At Tristel, compliance is at the heart of everything we do. Using our decades of experience, we ensure our products and processes meet the highest safety, health and regulatory standards. Our commitment to compliance guarantees that every solution we provide is both effective and reliable, giving our customers peace of mind while safeguarding the well-being of patients and healthcare workers alike.
Device and Material Compatibility
Our Devices and Materials team ensure our products are compatible with medical devices. They work closely with manufacturers and provide expert support to Tristel customers across the world.
Health and Safety
Our Health and Safety team ensure product safety through comprehensive data sheets, regulatory compliance and expert guidance on hazardous materials, providing essential safety information worldwide.
Quality and Regulatory
Our Quality and Regulatory teams ensure our products meet the highest standards of safety and compliance, delivering reliable solutions that adhere to global regulations and exceed customer expectations.
Our certifications:
Certificate of Registration MDSAP 703572
ISO 9001:2015 Certificate 553285
EC Certificate – Full Quality Assurance System CE 544967
ISO 13485:2016 Certificate 78322
Manufacturing
Tristel’s U.S. partner, Parker Laboratories, based in Fairfield, New Jersey, manufactures Tristel ULT and Tristel Duo OPH for North America.
Parker Laboratories is a leading global medical products company that develops, manufactures and sells ultrasound and electromedical contact media, as well as leading lines of institutional cleaners and disinfectants. The company is focused on consistently providing products that meet or exceed industry standards and customer expectations. Parker is registered with the U.S. Food and Drug Administration as a manufacturer of medical devices and all products are produced under Good Manufacturing Practices (GMP) directives. Parker Laboratories products are available in every country throughout the world and medical practitioners everywhere recognize Parker for quality and dependability.
