Rontis Hellas S.A.

CLOSEOUT LETTER Rontis Hellas S.A. MARCS-CMS 695160 — February 26, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Mr. Anastasios Politopoulos Recipient Title CEO Rontis Hellas S.A. Rontis Hellas S.A. Industrial Area of Larissa 41500 Larissa, Thessaloniki Greece Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Mr. Anastasios Politopoulos: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #695160 dated October 28, 2024). Based on our evaluation of the evidence provided in your Warning Letter response #5 (received by FDA on December 31, 2025), it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ for Bram Zuckerman, MD Director OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: Jessica Osward-McLeod Nipro Medical Corporation 3150 NW 107th Ave. Miami, Florida 33172, USA jessicao@nipromed.com Content current as of: 03/12/2026 Regulated Product(s) Medical Devices