Merete Medical GmbH

CLOSEOUT LETTER Merete Medical GmbH MARCS-CMS 571091 — July 05, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Alexia Anapliotis Recipient Title CEO Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Issuing Office: Center for Devices and Radiological Health United States Dear Alexia Anapliotis: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 571091, dated December 31, 2018). 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/ CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC US Agent: Marc Kneissler One Lincoln Centre 18W140 Butterfield Road, 15th Floor Oakbrook Terrace, IL US 60181 Email: Mkneissler@Merete-Medical.Com Content current as of: 07/05/2022 Regulated Product(s) Medical Devices