A large US-based manufacturer and supplier of LVLP saline nasal irrigation systems in the world approached Freyr for UDI submission services. The client was aiming to place their moderate risk Class II device on the US market. Though the product in scope was CE marked and ISO certified, identifying the right GMDN codes, checking the availability of the requisites and accurate data sets and identifying and rectifying the validation errors in the final data was a challenging task. However, Freyr ensured to prepare accurate data for UDI submission and identified the related data sets along with the GMDN codes, within the defined timelines.
Discover how Freyr provided hassle-free UDI submission support to the US-based client by utilizing Freyr’s in-house UDI tool. Download the proven case.