FOI release

CE certification of Allergan N-TRX340 and N-TRX375

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2026/01114

Received 23 September 2026

Published 6 November 2026

Request

Please treat this email as a request under the Freedom of Information Act 2000. Please provide any record held by the MHRA confirming the CE-certification status on 28 March 2012 of the following breast implants: * Allergan Natrelle INSPIRA TRX * Catalogue references N-TRX340 and N-TRX375 * Notified body: GMED 0459 If the certificate itself cannot be provided, please confirm: 1. The relevant certificate number; 2. Its period of validity; and 3. Whether N-TRX340 and N-TRX375 were covered by a valid CE certificate on 28 March 2012. This information is required to verify the historical regulatory status of these medical devices. Please provide the information electronically by return email.

Response

See attached

Documents

• FOI2026_01114 (redacted).pdf (476.3 KB)

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