USP Class VI Approved Covert Solutions
Authentix can provide solutions to permanently and covertly mark all or certain components of medical devices, allowing manufacturers to confirm authenticity directly in the field. With USP Class VI Certification, our technology can be integrated directly in certain raw materials and manufacturing of polymer based materials.
Authentix Can Protect Most Polymer Based In Vivo Medical Devices or Components Such As:
- IV Bags and Tubes
- Fittings and Closures
- …and much more
About USP Class VI Certification
Authentix covert solutions for medical devices are USP Class VI Certified for in vivo applications using polymer-based components. The United States Pharmacopeia and National Formulary (USP-NF) is a non-profit organization responsible for testing materials for bio-toxicity. The goal of the testing is to ensure no toxic materials will be extracted when a product comes in contact with human tissue or injectable drugs or other products manufactured relating to healthcare, pharmaceuticals, or medical devices. Class VI testing has the most stringent criteria and involves 3 tests that evaluate reactions for toxicity in tissue. Passing the test means the material is not toxic and does not leach potentially harmful substances into fluids or tissue.
Partnering to Protect Medical Devices from Compromise
Authentix has partnered with Foster Corporation, a leader in material solutions for the “critical application” healthcare market, to provide a covert and integrated brand security feature in their polymers and coating systems presently used for catheters, IVs, stents and more. For thirty five years Foster Corporation has been a leading supplier of custom compounds for medical devices…blending medical grade polymers with performance additives or other polymers to achieve properties specific to each application. The addition of the new integrated brand protection features from Authentix enables verification of authenticity of the products in the supply chain protecting the patient, health care practitioner, and brand owner from counterfeit or substandard products.