Unimicro Medical Systems Shenzhen Co., Ltd.

CLOSEOUT LETTER Unimicro Medical Systems Shenzhen Co., Ltd. MARCS-CMS 624560 — May 18, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Medical Devices Recipient: Recipient Name Roly Lee Recipient Title General Manager and Co-Founder Unimicro Medical Systems Shenzhen Co., Ltd. 201, Bldg 38 101 Heshui Kou Gongmingzhen Longgang Shenzhen 518106 China Issuing Office: Center for Devices and Radiological Health United States Dear Roly Lee: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #624560 dated 01/06/2022. 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 yours, /S/ Courtney H. Lias, Ph.D. Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: Zeyu Chen 238 Fernwood Ave, Edison, New Jersey 08837 Content current as of: 05/31/2023 Regulated Product(s) Medical Devices