Flux Lab Pte. Ltd. d/b/a The Fluxion

CLOSEOUT LETTER Flux Lab Pte. Ltd. d/b/a The Fluxion MARCS-CMS 720847 — March 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Yan Nie Recipient Title Director Flux Lab Pte. Ltd. d/b/a The Fluxion 60 Paya Lebar Road #12-03 Paya Lebar Square 409051 Singapore support@thefluxion.com Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Yan Nie: The Food and Drug Administration (FDA) has completed an evaluation of Flux Lab Pte. Ltd. d/b/a The Fluxion corrective actions in response to our Warning Letter CMS #720847, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(s) 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/ Michael J. Hoffmann Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 04/07/2026 Regulated Product(s) Medical Devices