Jiangsu Caina Medical Co. Ltd.

CLOSEOUT LETTER Jiangsu Caina Medical Co. Ltd. MARCS-CMS 687033 — August 24, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Jun Lu Recipient Title Board Chairman Jiangsu Caina Medical Co. Ltd. No. 23 Huanxi Road Zhutang Town Jiangyin City Jiangsu Sheng , China Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Mr. Jun Lu: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS#687033 issued July 18, 2024. Based on our evaluation, 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/ Michael J. Hoffmann Director Office of Health Technologies 3 Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: DJ Fang us-agent@purefda.com Content current as of: 08/31/2026 Regulated Product(s) Medical Devices